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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; LASER THERAPY PRODUCT

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; LASER THERAPY PRODUCT Back to Search Results
Model Number PED2-450-20
Device Problems Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/28/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the pipeline was twisted and failed to open in the middle during deployment, and then became stuck in the marksman catheter.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the internal carotid artery with a max diameter of 5mm and a 4mm neck diameter.It was noted the patient's vessel tortuosity was normal.It was reported that the pipeline was delivered through the marksman microcatheter to the treatment location.When unsheathed, the pipeline was twisted in the middle.Re-sheathing was attempted, but the physician could not.The physician tried to un-sheath again but could not.As a result, the system was removed from the patient.Outside of the patient, thepipeline was attempted to be transferred into the introducer sheath, but the pipeline became stuck in the marksman hub.A new pipeline and an excelsior xt 27 were used to finish the case.Post-procedure angiographic results were normal.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.It was reported that the pipeline had been placed in a vessel bend when it failed to open.Ancillary devices include a longsheath, guider softip, marksman, transend.
 
Manufacturer Narrative
H3: the pipeline flex w / shield (model: ped2-450-20, lot: b026784) and marksman micro catheter (model: fa-55135-1030, lot: 218379400) were returned for analysis.The pipeline flex w / shield pusher was found bent at ~137.4cm from the proximal end.The distal hypotube was found stretched.No damages or irregularities were found with the re-sheathing pad.The distal wire was found broken between the resheathing pad and dps sleeves.The pipeline flex w / shield braid and distal wire was found within the marksman micro catheter hub.The marksman micro catheter total length was measured to be ~144.7cm and the usable length was measured to be ~136.9cm which is within specification (specification: total (reference) = 142cm ± 3cm, usable = 135cm ± 3cm).The inner diameter was measured to be 0.027¿ which is within specification and compatible for use with the pipeline flex w / shield.No flash or voids molded were found within the catheter hub.No damages or anomalies were found with the hub.Dried blood was found within the hub.The marksman micro catheter body was found flattened at ~27.3cm, ~15.6cm and ~6.6cm from the distal end as well as just proximal to the distal marker band.No damages or irregularities were found with the distal tip or marker band.The micro catheter was flushed with water and water did not exit out from the catheter tip.A mandrel was used unsuccessfully to push out the distal wire and braid.The marksman catheter was cut to remove the braid / distal wire.The distal wire was lost during the extraction and could not be assessed.The distal broken end was sent out for sem testing.Once deployed out of the micro catheter, the distal, middle and proximal ends of the pipeline flex shield braid were found fully opened, with the proximal end frayed and the distal end found frayed / damaged.No other anomalies were observed.Based on the analysis findings, the pipeline flex shield and marksman were confirmed to have ¿resistance in catheter hub¿ and ¿resistance during re-sheathing / failure to resheath¿ as the distal wire and braid were found stuck within the hub.Possible causes are patient vessel tortuosity, braid damage, pushwire damage, catheter damage, user does not maintain continuous flush or incompatible catheter.Customer report patient vessel tortuosity as normal and devices were prepared as per ifu.The pipeline flex w / shield and the marksman catheter were found damaged.From the damages seen on the catheter body (flattened), pipeline pusher (bent), hypotube (stretched), distal wire (break) and braid (frayed / damaged); it appears there was high force used.It is possible these damages occurred when the customer attempted to advance/retrieve the pipeline flex shield through the marksman catheter against resistance.Possible contributors towards the failure are patient vessel tortuosity or lack of continuous flush.There was no non-conformance to specifications identified that led to the reported issues.Per our instructions for use (ifu): "discontinue delivery of the device if high force or excessive friction is encountered.Identify the cause of the resistance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an intralumenal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw t he catheter.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ sem results: ¿the wire failed via torsional overload¿.The customer report of ¿failure / incomplete open at middle section (hourglass shape)¿ could not be confirmed as the device fully opened when deployed out of the micro catheter.Possible causes for failure are patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid overstretched during deliver, user deploys braid in vessel bend, presence of other indwelling endovascular stent and inappropriate anatomy.Customer reported the device was placed within a bend.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
 
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Brand Name
PIPELINE FLEX W/SHIELD TECHNOLOGY
Type of Device
LASER THERAPY PRODUCT
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
MDR Report Key10371429
MDR Text Key202946074
Report Number2029214-2020-00774
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/18/2023
Device Model NumberPED2-450-20
Device Catalogue NumberPED2-450-20
Device Lot NumberB026784
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2020
Date Manufacturer Received10/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age59 YR
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