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U.S. Department of Health and Human Services

MedSun: Newsletter #63, August 2011

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Newsletter #63, August 2011

Articles

Silencer S2200 Centrifuge by Global Focus Marketing & Distribution, Ltd.: Class I Recall

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FDA MedWatch Safety Alert

There is a potential for a centrifuge's bucket and insert not being seated on the rotor, breaking the lid and being forced out of the centrifuge. This could result in serious personal injury and damage to the surrounding area. Customers who have one of these affected units should STOP using the S2200 and contact Global Focus Marketing & Distribution, Ltd.

Additional Information:

FDA MedWatch Safety Alert. Silencer S2200 Centrifuge by Global Focus Marketing & Distribution, Ltd.: Class I Recall. July 27, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm265707.htm

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Mobile Medical Applications

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FDA Medical Devices: Products and Medical Procedures

Through draft guidance release on July 19, 2011 the FDA defined a small subset of mobile medical apps that may impact on the performance or functionality of currently regulated medical devices and as such, will require FDA oversight. The FDA encourages feedback from manufacturers, health care providers and others on how its proposal may support the balance between promoting innovation and assuring safety and effectiveness.

Additional Information:

FDA Medical Devices: Products and Medical Procedures. Mobile Medical Applications. July 25, 2011.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ucm255978.htm

FDA Consumer Update. FDA Proposes Health 'App' Guidelines. July 29, 2011.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm263332.htm

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Update on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse

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FDA Safety Communication

The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.

Additional Information:

FDA Medical Devices: Products. UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse. July 13, 2011.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm

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LabNet

GEM Premier 4000 PAK Cartridges for Use on the GEM Premier 4000 System: Class I Recall - Inaccurate Results

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FDA MedWatch Safety Alert

Potassium test results on the GEM Premier 4000 are too low when compared to a reference analyzer; with biases exceeding the allowable error claim of plus or minus 0.5 mmol/L by as much as 2.0 mmol/L. Use of this product may lead to inappropriate patient treatment and may cause serious adverse health consequences, including death. These products were manufactured and distributed from May, 2006 through July 2011. Customers were directed to follow the instructions to disable the potassium test to eliminate the potential of erroneous result reporting.

Additional Information:

FDA MedWatch Safety Alert. GEM Premier 4000 PAK Cartridges for Use on the GEM Premier 4000 System: Class I Recall - Inaccurate Results. August 1, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm266113.htm

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Laboratory Medicine Best Practices: Systematic Evidence Review and Evaluation Methods for Quality Improvement

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PubMed Abstract

Adapting and developing methods from validated systems and applying them to systematically review and evaluate practices in LM by using published and unpublished studies is feasible. With these methods, evidence from quality improvement studies can be systematically synthesized and summarized to identify effective LM practices. Practical and scientifically validated demonstration of a positive impact on outcomes ensures that practitioners, policy makers, and decision makers at all levels have the evidence needed for improving healthcare quality and public health.

Additional Information:

PubMed Abstract. Laboratory Medicine Best Practices: Systematic Evidence Review and Evaluation Methods for Quality Improvement. June 2011.
http://www.ncbi.nlm.nih.gov/pubmed/21515742?dopt=Abstract

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Safety Tip: Develop Specific Work Practices for Individual Experiments

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Lab Manager Magazine

LSI believes that the scope of particularly hazardous substances should be expanded. There are others in the lab that may need some additional precautions. We would like to see highly flammable (class IA solvents), highly corrosive (concentrated and fuming acids), and highly reactive substances (picric acid, explosives).

Additional Information:

Lab Manager Magazine. Safety Tip: Develop Specific Work Practices for Individual Experiments. June 7, 2011.
http://www.labmanager.com/?articles.view/articleNo/4758/article/Safety-Tip--Develop-Specific-Work-Practices-for-Individual-Experiments

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HeartNet

Alarming Monitor Problems

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FDA Medical Device Safety

A search of the FDA's Manufacturer and User Facility Device Experience (MAUDE) database yielded 566 alarm related death reports from 2005 to 2008. Follow-up investigations often showed that users weren't familiar with how the monitoring equipment worked or hadn't checked the monitor's alarm status. This article includes precautions that users can take to help prevent these issues.

Additional Information:

FDA Medical Device Safety. Alarming Monitor Problems. September 2009.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm222022.htm

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HomeNet

Patient-Assisted Incident Reporting: Including the Patient in Patient Safety

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PubMed Abstract

Patient Safety Reporting Systems are a commonly used method for capturing information about adverse events and near misses in the acute care setting. These event reports are almost exclusively submitted by the frontline care provider, and the patient perspective of the event is rarely captured. The authors present a case which illustrates the use of eliciting the patient's perspective to provide a complementary perspective to the provider's description of the event. The methodology for obtaining and using this information to enhance understanding of the event and to inform prevention strategies is described.

Additional Information:

PubMed Abstract. Patient-Assisted Incident Reporting: Including the Patient in Patient Safety. June 2011.
http://www.ncbi.nlm.nih.gov/pubmed/21577079

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KidNet

Pediatric Medical Devices

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FDA Medical Devices: Products and Medical Procedures

Pediatric medical devices treat or diagnose diseases and conditions from birth through age 21. Some products are designed specifically for children, while others are borrowed from adult applications or produced for more general use. Designing pediatric medical devices can be challenging: children are often smaller and more active than adults, body structures and functions change throughout childhood, and children may be long-term device users -- bringing new concerns about device longevity and long-term exposure to implanted materials.

Additional Information:

Pediatric Medical Devices. FDA Medical Devices: Products and Medical Procedures. January 2011.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ucm135104.htm

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Highlighted MedSun Reports

Highlighted Reports

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This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives. In some instances the reports have been summarized and/or edited for clarity. The entries that follow represent a cross section of device-related events submitted by MedSun reporters during the period May 1 through May 31, 2011. All other reports can be searched under the ‘MedSun reports’ menu pane. Note: the two month delay is due to quality control and follow-up.


ANESTHESIOLOGY

Device:
Type: Patient Circuit
Manufacturer: Vapotherm, Inc
Brand: Precision Flow
Model#: PF-DPC-LOW
Lot #: 09122110430
Cat #: PF-DPC-LOW
Other #: DWP Assembly

Problem:
While therapist was setting up Vapotherm unit, the circuit leaked. This had not been connected to the patient; problem discovered during setup. This correlates to a previous report submitted. Since this failure, Vapotherm has exchanged out all of our stock of this circuit with their newly designed version. Our opinion of this new design is that this leaking problem has been resolved and there is a more positive latching mechanism.
======================
Manufacturer response for Patient Circuit, Precision Flow (per site reporter)
======================
Manufacturer provided RGA [Return Goods Authorization] for product return evaluation.


CARDIOVASCULAR

Device 1:
Type: Catheter, Ablation, Rf, Cardiac
Manufacturer: St. Jude Medical
Brand: Safire Blu
Lot #: 3301954
Cat #: A402872
Other #: 1304-CPS-7-25-LC-BD

Device 2:
Type: Catheter, Ablation, Rf, Cardiac
Manufacturer: St. Jude Medical
Brand: Safire Blu
Lot #: 3306168
Cat #: A402872
Other #: 1304-CPS-7-25-LC-BD

Problem:
During an Atrial fib ablation, the doctor used two St. Jude Safire BLU ablation catheters. He experienced noisy signals at high energy and high power. He felt the steering ability/steering shaft of the catheter was broken during the procedure. The first catheter was used for approximately 3 hours at 29 ablations when an increase in noisy signals occurred along with the inability to steer the catheter appropriately. A second Safire BLU catheter was then used for just over one hour and 19 ablations when steering inability occurred. The physician removed this catheter and then a Blazer II catheter was used without difficulties. The patient's outcome was successful without complications. The St. Jude rep was in the room during the case and did not have any suggestions as to why the catheter was getting noisy signals. The catheters were given to the sales rep for return to St. Jude Medical.


Device:
Tye: Catheter, Intravascular, Diagnostic
Manufacturer: Merit Medical Systems
Brand: Impress, Mod. Hook Flush
Model#: 565386MHK-NB
Cat #: 565386MHK-NB

Problem:
While the surgeon was inserting the wire through the pigtail catheter it was observed that the wire went through the bottom part of the pigtail catheter, not the tip of the pigtail catheter. While trying to remove the pigtail catheter the tip of the catheter dislodged inside the sheath. The surgeon then converted the case to an open procedure and the catheter tip was removed and the artery repaired.

A possible contributing factor may include how the product is removed from the packaging tray. The catheter could be pulled out of the tray or the tray could be bent open to free the catheter.


Device:
Type: Electrode, Defibrillator
Manufacturer: Covidien, Formerly Kendall A Division of Tyco Healthcare
Brand: Medi-trace, Cadence
Model#: 22660R
Cat #: 22660R

Problem:
HeartStream equivalent pad #22660R. When pad is removed from patient's skin, the pad adhesive also removes the patient's skin.

Manufacturer response for Electrode, Defibrillator, Medi-Trace, Cadence (per site reporter): Only sales rep made aware of issue at this time.


Device:
Type: Lead, Defibrillation
Manufacturer: St Jude Medical
Brand: Durata
Model#: 7170Q/58
Other #: SJ4-LLHH

Problem:
An attempt was made to reposition a right ventricular (RV) lead in the cath lab but adhesions made it difficult to reposition the device. The plan was to remove the lead, but as the physician pulled it, the core of the lead (the tip attached to the wires) broke away from the coils and insulation. Multiple attempts to snare the lead tip were made and eventually the lead was retrieved. A new lead was then able to be placed. There was no harm to the patient as a result of this event.
======================
Manufacturer response for ICD lead, (brand not provided) (per site reporter)
======================
They would like equipment back to investigate and analyze it.


Device:
Type: Lead, Pacemaker
Manufacturer: Medtronic, Inc.
Brand: Capsurefix Novus
Model#: 5076-65

Problem:
The ventricular lead was defective. The stylet used to guide the lead did not fit the inner cannula. The inner cannula of the lead was torn by the stylet. The patient was discharged the next day and is doing well.


EAR, NOSE, & THROAT

Device:
Type: Emg Endotracheal Tube
Manufacturer: Medtronic
Brand: Emg Endotracheal Tube
Model#: 8229306
Lot #: 66466400
Other #: size 6mm

Problem:
Patient was intubated with the EMG Endotracheal Tube by the anesthesiologist and placement confirmed. Shortly after intubation the patient became very difficult to ventilate and O2 saturation began dropping and tidal volume dropped greatly. At that time the EMG tube was removed and patient was ventilated via bag mask and chest compressions were started due to drop in heart rate and BP. The patient was reintubated immediately with a standard ET tube. Once the standard tube was placed proper ventilation was achieved with good O2 saturation and improved HR and BP. Upon inspection of the EMG tube it was discovered that the tube had collapsed causing the drop in vital signs and tidal volume. The tube was secured by the OR manager. The patient's vital signs became stable and the cervical case proceeded forward without any further complications.


GENERAL & PLASTIC SURGERY

Device:
Type: Endowrist Bipolar Cautery Instrument
Manufacturer: Intuitive Surgical, Inc.
Brand: Pk Dissecting Forceps
Model#: 420227
Other #: 8mm Cautery Insrument

Problem:
The forceps worked during the surgery. The thought is that the defect occurred during the cleaning process. There is a small black wire that broke during what the staff believes when cleaned. The forceps will not open and have been taken out of service.

See device images:

Image of Endowrist PK Dissecting Forcep.  Shows forceps separated from the shaft

Image Endowrist PK Dissecting Forcep.  Shows forcep in a closed position with small black broken wire protruding from shaft.

Endowrist PK Dissecting Forcep.  Two separate images of the forecp in a closed position.  Left image shows closed forcep without the broken black wire protruding from the shaft.  The right image shows the closed forcep with the black broken wire protruding from the shaft.


Device:
Type: Endowrist Monopolar Cautery Instruments
Manufacturer: Intuitive Surgical, Inc.
Brand: Permanent Cautery Spatula
Model#: 420184
Lot #: m10101110962
Other #: 8mm instrument

Problem:
When removing Endowrist instrument from cannula, spatula was not coming out. Tip of instrument missing a piece on visualization. MD notified and inspected op site. Company representative was in room and is aware of issue. Called company. Device not radiolucent. Risk MD from company said tip will not harm patient.


Device:
Type: Spacemaker Plus Dissector System
Manufacturer: Covidien
Brand: Spacemaker Plus
Model#: SMSBTRND
Lot #: PIC 1112

Problem:
A Spacemaker Plus Dissector System was opened on back table. The patient is allergic to latex. Per the patient, latex "burns his skin". The product box or peel pack was not labeled "contains latex". Upon further investigation by the RN it was found in small print on the product insert that the product does, in fact, contain natural rubber latex. The product did not come into contact with the patient. The physician was notified along with the rest of the surgical team. The patient was given a prophylactic dose of benadryl by anesthesia at the instruction of surgeon. The patient showed no signs of anaphylaxis or distress at the end of the case and was transported to PACU.


GENERAL HOSPITAL

Device:
Type: Bed Frame
Manufacturer: Hill-Rom
Brand: Harbor Glen Furniture Collection
Cat #: 146584

Problem:
Patient was able to thread a sheet through an opening in the bottom of the bed frame, stand the bed on end and hang himself.


NEUROLOGY

Device:
Type: Neurological Stereotaxic Instrument
Manufacturer: MEDTRONIC NAVIGATION, INC.
Brand: Stealth Treon
Model#: Treon

Problem:
During movement of the machine it was noticed that the arm that holds the display was sitting at an unusual angle. Upon manipulating the arm, it came apart at one of the joints. The display is very heavy and had to be held up with a strap to prevent it from falling. There was no injury, but the display is typically located near the patient's head during surgery. There was a delay to the surgery as another machine had to be used. The joint that came apart was apparently press fitted and worked its way loose over time.

See device images:
Image of Treon Stereotaxic Instrument. Shows entire system.  Image shows the arm that holds the display sitting at an unusual angle.  Arm came apart at one of the joints.  You can see the strap that is holding display to keep from falling.

Image of the joint that came apart.  It worked its way loose over time.

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Medical Device Problem Summaries

Summary of MedSun Reports Describing Problem With Coronary Stents

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Coronary stents are small metal or wire mesh tubes used to prop open a stenotic or narrowed coronary artery, or saphenous vein. Stents are inserted using a specialized balloon catheter during angioplasty or percutaneous coronary intervention (PCI). Stents may be coated with medication released over time after implantation. (Food and Drug Administration Product Code Classification, 2011).

Over the past 2 years, MedSun has received 23 adverse event reports associated with this device type manufactured by Abbott Vascular, Boston Scientific Corporation, and Medtronic Vascular. The reports were submitted by 19 hospitals between January 2009 and May 2011.

The reported device problems were:
•Failure to deploy (3)
•Failure to advance (3)
•Positioning Issue (3)
•Component missing (1)
•Material separation (1)
•Difficult to remove (1)
•Detachment of device component (1)
•Premature deployment (1)
•Inadequate instructions for healthcare professional (1)
•Out-of-box failure (1)
•Material rupture (1)
•Break (1)
•Uncoiled (1)
•Dislodged or dislocated (1)
•Entrapment of device or device component (1)
•Occlusion within device (1)
•No information (1)

Of the 23 reports, the most frequently reported patient problems listed below were:
•Device fragment/foreign body in patient (6)
•Chest pain/cardiac arrest (4)*
•Dissection/impaired vasculature (2)
•Device explanation required (2)
•Embolus (1)

*Two post procedural deaths were reported after symptom of chest pain and cardiac arrest. There were no patients under the age of 21 years. Of the 23 reports listed, 4 involved female patients and 19 involved male patients.

These MedSun reports summarized above, in addition to manufacturer, healthcare, and voluntary reports contributed to FDA awareness of the device problems.

The following recalls are associated with coronary stents since 2009. The MedSun reported events may, or may not, be involved in the recall(s) listed.

Recall Number: Z-0068-2010 (Class II)
Date Posted: 10/21/2009
Product: Liberte©® Bare-Metal stent
Code Information: Material Batch H7493893412270 9049696 H7493893412270 9057624 H7493893412270 9099450 H7493893412270 9139074 H7493893412270 9160483 (truncated)
Recalling firm/Manufacturer: Boston Scientific Corporation
Action: Boston Scientific initiated a field correction for the Liberté® Bare-Metal coronary stent products. They have received reports from cardiac cath labs that TAXUS Liberte Paclitaxel-Eluting (TAXUS® Liberté® Drug-Eluting) coronary stents have been inadvertently selected when the interventional cardiologist intended to implant a Liberté® Bare-Metal stent, and Liberté® Bare-Metal stents have been inadvertently selected when the interventional cardiologist intended to implant a TAXUS® Liberté® Drug-Eluting stent. Selecting the wrong device may present a risk of serious injury, including death. Because of the importance of accurate device selection to patient safety, Boston Scientific is renaming the Liberté® Bare-Metal stent. The new name is VeriFlex" Bare-Metal. Representatives from Boston Scientific will be visiting all impacted health care facilities to re-label the outer boxes of all existing Liberte® Bare-Metal stents held in inventory, to reflect the new name.
Distribution: Nationwide, including Puerto Rico ( 391,769 devices)
Information Online: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=85496


Recall Number: Z-1367-2011
Date Posted: August 21, 2009
Product: Endeavor Resolute Zotarolimus-Eluting Coronary Sten System with Rapid Exchange Delivery System
Code Information: Lot Numbers: V00265135, V00265136, V00265137, V00265139, V00265140, V00265141, V00265142, V00265143, V00265144, V00265145, V00265146, V00265147, V00265148, V00265149, V00265150, V00265151, V00265152, V00265153, V00265154, V00265155, V00265156, V00265157, V00265158, V00265159, V00265160, V00265161, V00265169, V00265170, V00265171, V00265177, V00265178, V00265179, V00265180, V00265181, V00265182, V00265183, V00265188, V00265189, V00265190, V00265191, V00265194, V00265195, V00265196, V00265223, V00265224, V00265232, V00265244, V00265251, V00265254
Recalling Firm: Medtronic Vascular Galway Limited
Action: The firm, Medtronic, sent their initial "Urgent Medical Device Recall Notice" to customers with affected product via e-mail on August 7, 2009. An additional "Urgent Medical Device Recall Notice" was sent to all customers on August 12-13, 2009 via FedEX and UPS. The notice described the product, problem and action to be taken by the customers. The customers were instructed to remove the affected units from their inventory and isolate the units in a secure location to prevent additional use. A Medtronic CardioVascular Clinical Customer Service (CCS) representative will contact their site to arrange for return of the units. This will be followed by a shipment of replacement units to their sites.
Distribution: Nationwide
Information online: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84457


The following table lists the MedSun reports that are described in the device problem summary above.
[Note: The reports have been edited for clarity]

MedSun Reports Describing Problems with Coronary Stents
Device Manufacturer and BrandDevice Identifiers (Catalog Number, Model Number, Lot Number) Event Description
Abbott Vascular Inc., Multi-Link Mini Vision OTW NA, 1010152-12, 7013031 The cardiac stent improperly deployed during the procedure and was lost in vasculature. It was located next day.
Abbott Vascular Inc., Multi-Link Vision Rx NA, 1007849-23, 8041731 The stent catheter entered body without a stent on the balloon to deploy. A 0.014/190 cm filter wire was advanced through the guiding catheter into the distal portion of the vein graft. A 3.5/15 mm balloon dilatation catheter was then advanced over the guide wire and positioned in the mid vessel. Two inflations were performed at a maximum of 10 atmospheres. The balloon was removed and replaced with a 4.0/23 mm vision stent. This was deployed in the mid vessel at a maximum of 10 atmospheres. The stent delivery balloon was removed and repeat angiography showed the stent was patent but there was haziness in the proximal lesion. Therefore, a 3.5/23 mm vision stent was advanced over the guide wire and the balloon was inflated but there was no stent on the balloon. The balloon inflated to 10 atmospheres. The balloon was removed and replaced with a 3.5/23 mm vision stent. This was positioned in the lesion and deployed at 10 atmospheres. The stent delivery balloon was then removed. Repeat angiography showed sluggish flow in the vessel. The filter wire was then retrieved and the catheter was removed from body and kept.
Abbott Vascular Inc., Vision 2.0-12 VISION, NA, 9012641 The MD was placing the stent in right coronary artery(rca) when the stent separated from the delivery system and remained in RCA. The stent was subsequently crushed to side of the vessel and remains in patient’s RCA.
Abbott Vascular Inc., Jostent Covered Stent 3.5 MM/16 MM, NA, NA The patient underwent several passes w/ 1.5mm arthrectomy device at low speed. It was removed with guidewire entrapped. A new guidewire was inserted with difficulty. A balloon was deployed due to bleed. A jostent covered sent 3.0mm/ 16mm was deployed, then a second one was deployed, but would not cross first one. A balloon was inserted to allow for passage of the stent. The balloon caused the jostent stent to be stripped from the deployment device. The stent wedged into the proximal posterior tibial artery undeployed. Attempts to snare the stent were unsuccessful. A stent from another manufacturer was deployed and crushed jostent stent.
Medtronic Vascular, Endeavor Rx 3.5X18MM, NA, 900803 During coronary percutaneous coronary intervention (pci) a 3.5x18 drug eluting stent (DES) easily crossed lesion. However, during deployment, the balloon would not hold pressure. The balloon was withdrawn easily but the stent came off the balloon and lodged in the proximal circumflex artery near the left main. The patient was stable and sent to the OR for coronary artery bypass graft (CABG).
Boston Scientific Corporation, Liberte NA, NA, 12525756 The plan was to deploy the stent without pre-dilatation. The entire unit was removed from the coil protector and when the dilator was pulled off, the revap tool and the stent itself also came off. The decision was made by the interventionalist to proceed to use the balloon for pre-dilatation then asked for another stent which worked fine.
Boston Scientific Corporation, Liberte Bare Metal Stent NA, NA, NA The patient had a cardiac catheterization with stent placement. The physician requested a Liberte bare metal stent and was given a Taxus Liberte (drug eluting) stent. The Taxus Liberte was deployed and documented by nursing in the patient's medical record. The patient was given a wallet card bearing this information. The physician documented in the medical record that he inserted a bare metal stent. Several months later in the process of clearing the patient for knee surgery, the patient's primary care provider wanted/needed to discontinue the antiplatelets and discovered a discrepancy between the stent he thought had been inserted vs. the information provided to him by the doctor who performed catheterization/stent placement. There was no harm to the patient. However, it was thought that the surgery might be delayed due to the need to continue aspirin and Plavix therapy. The physician who placed the stent stated that packaging for both stents were identical: Same box, same labeling. He does not see the box, and is only handed the equipment.
Boston Scientific Corporation, Liberte NA, NA, 11499022 The patient had a 2.75 x 12 liberte stent placed in the circumflex artery. The patient returned to the cath lab approximately one month later for another scheduled procedure. The physician was using a prime wire in the left anterior descending (LAD) artery when he began to have difficulty advancing and removing the wire. Eventually he was able to remove the wire. When the wire was removed, it appeared to have the stent from the first procedure attached to it. It appeared that somehow the wire moved through one of the struts of the stent and got caught.
Medtronic Vascular, Microdriver Rx DRV25018UX, DRV25018UX, NA Patient with angina had angioplasty of a 90% obtuse marginal lesion. Attempts to maneuver two different stents to this area were unsuccessful. The patient developed chest pain approximately two weeks post-discharge and returned to the hospital. The cath films were reviewed and it was suspected that an undeployed stent was in the distal left main. The patient ultimately had triple bypass surgery after the initial heart cath (after return to the hospital) and the stent was removed.
Abbott Vascular Inc., Jostent Graftmaster NA, 106208-00/005, 537011 A 3.0 x 12 mm Jostent Graftmaster device was placed after left anterior descending (LAD) perforation during a cardiac cath procedure. This device initially seemed to adequately seal the perforation. However, the following day, the patient did suffer a cardiac arrest and expired. No autopsy done
Abbott Vascular Devices, Jostent Graftmaster GCG1630UA 3.0 X 16, NA, 580341 The physician was attempting to place a stent but the graft stent would not cross into the left anterior descending artery (lad). When the physician pulled it back out, the graft came off the balloon. The graft was stuck in the lad and was snared out. It would not pull out of the sheath, so the graft was stuck in the right profunda. It was felt that "due to wire bias against the vessel wall, it became trapped." The cath lab has contacted the manufacturer.
Abbott Vascular-Cardiac Therapies, Multi-Link Mini Vision Coronary Stent System 1007821-12, NA, 8022731 The physician was attempting to deploy a 2 x 12 mm stent in the left anterior descending artery. The physician had difficulty in advancing the stent past the mid vessel. The stent appeared to be catching on a previously deployed stent. The physician attempted to retrieve the stent but the stent would not come out. The physician was able to manipulate the stent until it came out, but the stent had dislodged from the balloon. The physician then introduced another stent into the left anterior descending artery. A 2 x 15 mm balloon was used to push the stent to the wall followed by a 2.5 x 15 mm stent. The stent was fully deployed and the dislodged stent was opposed into the wall with the new stent. There was no other intervention required
Boston Scientific Corporation, Veriflex NA, NA, 13008712 During left heart catheterization, a balance middle weight (BMW) wire was passed down into the circumflex branch. Initially a stent would not pass and then we placed a balloon. After pre-dilating the lesion a stent still would not pass in the more proximal portion of the vessel near a bend. Subsequently a guideliner catheter was placed to attempt to deliver the stent distally. This was not successful. The stent did not pass through the guideliner but the balloon did and an angioplasty of the distal portion of the vessel was completed. There was evidence of a dissection after the equipment was removed. Subsequently, there was evidence of loss of a small obtuse marginal (OM) branch. At this point, the bypass team was called for. Initially a stent was placed distally. Subsequently after pre-dilation of the more proximal area, another stent was placed proximally. These were 4.5 stents and were not drug-eluting. Subsequently a 2.5 promus stent was placed in the more distal portion of the OM branch. This was after evidence of new disease was seen there. The patient received intermittent doses of intracoronary nitroglycerin. The patient had transient chest pain. It was felt secondary to the loss of a very small distal portion of the circumflex. Next, hemostasis was achieved after angiography of the right external carotid artery. The patient was chest pain free by the termination of the procedure.
Abbott Vascular-Cardiac Therapies, Multi Link Vision NA, 1007850-18, 8101641 The stent was prepped in the standard fashion. The MD and scrub tech verified that the stent was never touched prior to insertion into the patient's body. After the stent was in the vessel and across the lesion, the MD noted that the stent was distal on the balloon, such that the stent was not located appropriately to the markers, and was more distal on the balloon than it should have been. At this point, the MD decided that to deploy the stent, a section of the stent may not inflate. It was decided to remove the stent. This was done successfully. After the stent was out of the body, the stent was evaluated. It was checked to see if it was "loosely" fitted around the balloon, and it was x-rayed out to the body to check against the markers. It appeared to be positioned incorrectly on the delivery system, not as a result of its prep, or its insertion into the patient but possibly coming from the manufacturer that way. Fibers can be seen currently on the stent, but were placed there after the stent was removed from the patient. The stent was not touched prior to its use. Health professional's impression: MD was concerned that if he hadn't noticed the misaligned stent, that a section of the stent would have not been deployed. To then pass a balloon through an undeployed stent may have proven to be a challenge, and would have placed the patient at risk of an unsuccessful procedure.
Medtronic Vascular, Integrity Rx NA, NA, 4606263 Unsuccessful stent deployment occurred. No stent was found on the stent deployment device (SDS). The patient remained stable and the procedure continued. Another stent was placed. The first undeployed stent was left in the patient.
Boston Scientific Corporation, Veriflex NA, NA, 12942553 During the procedure a Veriflex bare metal stent 5.0x28mm was introduced and the balloon was inflated to as high as 22 atmospheres of pressure due to calcifications and the lesions not expanding properly. Post procedure, the patient complained of chest pain and vital signs began to decompensate resulting in a code being performed on the patient. The same balloon was inflated to the area in an attempt to tamponade. On removal of the balloon, it was noted that it had ruptured. Findings from the surgeon included: large vein graft to the obtuse marginal (OM) showed two 95% stenoses distally post percutaneous coronary intervention (PCI) with some difficulty due to heavy calcification and final stent deployment with a 5.0 x 28mm Veriflex inflated to high pressure due to the calcification that caused a perforation and code arrest leading to the death of the patient.
Abbott Vascular-Cardiac Therapies, Graftmaster NA, GCG1630UA, 645954 The physician attempted to deliver a Graftmaster Jostent to a left circumflex coronary artery aneurysm through the Xience stent placed in left main artery. Once in the distal left main artery, it was determined that the Jostent would most likely not reach the aneurysm site. The Jostent was withdrawn, at which time the stent dislodged in the mid segment of the left main artery. A 4mm microsnare Amplatz loose neck snare was utilized to retrieve the Jostent intact and without difficulty. The patient remained hemodynamically stable.
Abbott Vascular-Cardiac Therapies, Multi-Link Vision NA, 1007848-18, 22541 Following a stent placement to the circumflex artery, a second stent was attempted to be placed distal to the first stent. The second stent, while still on the delivery system, became lodged in the proximal portion of the initially placed stent. The physician attempted to remove the stent and delivery catheter, but was unsuccessful. Upon further manipulation, the end of the catheter, which contained the un-deployed stent, broke off of the catheter and remained in the vessel. The guidewire and remainder of the delivery system was removed. An unsuccessful attempt was made to remove the indwelling stent and catheter with a snare. The case was aborted and the patient was referred for surgical removal of the pieces.
Medtronic Vascular Inc, Integrity Rapid Exchange Coronary Stent System 240INT25026UX, M719010B001, 100005000000 A 2.5 x 26mm integrity stent was advanced into a tortuous calcified artery. The stent was not deployed, and was removed from the patient. When the stent was removed, it was noted that part of the stent had uncoiled and pulled away from the stent delivery system (SDS). All parts were still intact and nothing was left in the body.
Medtronic Vascular, Integrity Bare Metal Stent INT27526LIX, NA, 4689611 During placement of the stent in the right coronary artery (RCA), the stent was noted to be advancing ahead of the balloon. The stent was thought to have become dislodged from the balloon. A smaller balloon was placed in the patient and that balloon was inflated to trap the dislodged stent. Another stent was placed without complication.
Medtronic Vascular Inc, Luge NA, NA, 2152874 During an elective percutaneous coronary intervention (PCI), the physician noted that the Luge wire had fractured. The wire remained in the patient. The patient was transferred to another facility for higher level of care.
Abbott Vascular-Cardiac Therapies, Multi-Link Mini Vision Rx Coronary Stent System NA, 1007822-15, 0092741 Angiographic report: repeat angiography revealed what appeared to be a linear dissection in the diagonal branch. With a 3.0 x 15 mm balloon in the left anterior descending, a 2.25 x 15 mm Minivision stent was placed in the diagonal branch and deployed at 10 atmospheres with simultaneous inflation of the balloon in the left anterior descending. Kissing balloon angioplasty was performed using a 2.5 mm balloon in the diagonal and a 3.0 x 15 mm balloon in the left anterior descending to 8 atmospheres. Repeat angiography at this point revealed good stent expansion in both the left anterior descending and the diagonal. The guide wire was removed from the left anterior descending. Attempts to remove the guide wire from the diagonal resulted in the PT2 ms guide tip being entangled in the distal end of the diagonal stent and attempts to remove this were unsuccessful. Attempts to dislodge the wire tip using a 2.0 x 15 mm balloon and a 1.5 x 15 mm balloon were unsuccessful. A guideliner was also tried and attempts with the balloon to push the wire off the distal end of the stent were unsuccessful. With a 1.5 mm balloon in the diagonal branch to the tip of the guide wire, the wire was pulled resulting in lead tip fracture. The remaining guide wire and the 1.5 mm balloon were removed. Attempts to wire the left anterior descending using a wire were unsuccessful. A high-torque floppy wire was passed successfully due to the stent in the left anterior descending into the distal vessel. The left anterior descending was dilated using a 1.5 x 15 mm balloon to 8 atmospheres at 2.0 x 15 mm balloon to 14 atmospheres and a 3.0 mm balloon to 16 atmospheres. A 3.0 x 12 mm vision stent was then inserted, but would not pass. The proximal left anterior descending was again dilated using a 3.0 x 15 mm balloon to 12 atmospheres. A 3.0 x 12 mm vision bare metal stent was then placed proximally and deployed at 11 atmospheres post dilated using a 3.0 x 15 mm balloon to 18 atmospheres.
Boston Scientific Corp., Veriflex (Liberte)Bare Metal Coronary Stent System 38934-1635, NA, 14040504 Elderly male underwent a cardiac cath procedure. Following successful angioplasty of the posterior descending artery (PDA) & Veriflex bare-metal stent was deployed into the proximal right coronary artery (RCA) and was noted that one stent embolized in the distal portion of the RCA. The patient was brought back to cath lab suite. Selective angiography confirmed embolization of the undeployed stent at the distal portion of the RCA. Another bare-metal stent 3.5 x 12 was deployed across the proximal portion of the vessel. Post dilatation of both stents then performed with 3.25 x 8 non-compliant balloon. No residual stenosis. The used system was discarded prior to the identification of an issue.


Additional Information:

(2011). Product Classification. Retrieved from FDA Product Classification Website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm

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Updated August 1, 2011

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