Summary of MedSun Reports Describing Adverse Events With Transcatheter Septal Occluders
MedSun: Newsletter #24, May 2008

The purpose of providing this summary, and the following reports, is to inform you about problems reported to FDA by the MedSun clinical community. These, as well as non-MedSun reported problems involving this device may also be investigated by searching FDA’s on-line MAUDE database. See Additional Information below.


Transcatheter septal occluders are devices delivered through a catheter and placed to close defects (holes) in the septum (walls) between the two atria or the two ventricles of the heart.
Over the past 2 years, MedSun has received 10 medical device adverse event reports involving transcatheter septal occluders associated with three manufacturers: AGA Medical (8), NMT Medical (1) and W.L. Gore and Associates, Inc. (1). The reports were submitted by 6 hospitals between April 1, 2006 and April 17, 2008. The most frequently reported device problems are (please note, several problems are often reported in one report):

•Problems preventing implant of the device requiring removal (7)
•Migration of the device (4)
•Difficulty removing the device (2)

There are no MedSun reports involving a patient death during this time period. The most frequently reported patient problems are (again, more than one problem is often reported per report):

•Need for an additional surgical procedure or prolonged surgery (7)
•Need for removal of foreign body (3)
•Required hospitalization related to the event (3)

Of the reports that list patient age, 1 report has a patient age listed as less than 21 years and no reports have a patient age listed as greater than 21 years. All 10 reports listed patient gender; 5 reports involve female patients and 5 reports involve male patients.

These MedSun reports contribute to FDA’s post-market experience and understanding of problems associated with the use of these devices.
MedSun Transcatheter Septal Occluder Adverse Event Reports received between April 1, 2006 and April 17, 2008
Device Device Identifiers Event Description
AGA MEDICAL CORPORATION/Amplatzer Catalog: 9-ASD-019 Lot: M05G25-2B/TD>Upon release of the Amplatzer device across the atrial septum it became mis-aligned and became "free floating" in the left atrium. Device was captured with a snare but unable to retrieve. Device secured in position. Patient
to OR for retrieval and repair.
AGA MEDICAL CORPORATION/AMPLATZER Lot: M03C20-25 Patient with Large Secundum ASD (Atrial Septal Defect) had insertion of Amplatzer occluder device over a year ago. Within the past year, he has recently been hospitalized twice. Late last year, presented with blurred vision of left eye associated with headaches which occurred in A.M. extensive Neurology, Cardiology and Opthomology work up demonstrated left temporal field defect with abnormal fundoscopic exam and evidence of small microemboli effecting small area of optic nerve. Hyper coag work-up was negative. He then presented one month later with left arm and leg paresis. He had magnetic resonance venogram (MRV), magnetic resonance angiogram (MRA) and transesophageal echocardiogram (TEE). TEE demonstrated a small residual ASD in the superior part of the device of the superior vena cava (SVC) end. No clots or vegetation. Neurology symptoms were thought to be transient ischemic attacks (TIAS). Based on findings, all MDs involved in care determined that best course of action would be to remove device and repair ASD surgically, especially with recurrent TIAS in the absence of any other cause. Device was sent to pathology and not as much scar tissue was noted on the side that would have been nearest to the left side of the heart. Since removal, TIAS have stopped, blurred vision of left eye diminished.
NMT MEDICAL, INC./PFO CARDIOSEAL Model: 33MMThe patient had a Cardioseal device placed approximately one month prior for Patent Foramen Ovale (PFO). The patient had a history of prior stroke and presented with current visual disturbances and a near-syncopal episode. Transesophageal echocardiogram (TEE) revealed adequate closure of the Atrial Septal Defect (ASD). However, there were areas of thrombus adjacent to the closure device on the left atrial side. As a result, the closure device was removed and primary repair of the ASD was performed.
AGA MEDICAL CORPORATION/AMPLATZER Lot: M06K16-18Patient arrived on the unit, status post device closure of ASD (atrial septal defect). The patient was responsive on arrival with stable vital signs and was interactive. Within one hour of arrival on the unit, patient had sinus tachycardia after vomiting and returned to baseline. Ten minutes after emesis, patient complained again of persistent nausea, vomiting with red tinge in emesis and complaint of feeling unwell. Sinus tachycardia occurred while vomiting. Fellow was notified - 2 RNs were present at the bedside. Patient became unresponsive, eyes rolled back, frothing at the mouth. Code light was activated. Patient became bradycardic to 30, MD and RN staff responded to the event. Patient was tonic, pulseless, and apneic. CPR was initiated. Cardiac code was called with fast response by cardiac code team. 2 rounds 1ml 1:100,000 Epinephrine were administered resulting in return of heart rate to 70, sinus rhythm with perfusion, chest compression held with bag-mask ventilation. Oral airway was inserted. Transferred to other unit within 6 minutes of event onset.
AGA MEDICAL CORPORATION/AMPLATZER A 24MM Amplatzer device was placed in secundum for an (ASD) atrial septal defect. Position confirmed by TEE(transesophageal echocardiogram) and fluoroscopy. Immediately upon release of the device, it embolized into the left atrium (LA), and subsequently into the left ventricle (LV). Multiple attempts to retrieve the device were unsuccessful.Patient was
taken to the OR for operative removal of the device and closure of the ASD.
AGA MEDICAL CORPORATION/AMPLATZER Model: 10 FR 45 DEGREE X 80 CM Lot: M06J19-58
Patient undergoing atrial-septal defect repair. A 6 french standard sheath was placed in the right femoral vein. Then the intracardiac echocardiography (ice) catheter was advanced to the right atrium and under guidance from ice, a multipurpose catheter was utilized to go across the asd over a rozen wire. After this the balloon sizing Amplatzer balloon was utilized. This showed the ASD to be roughly 27 mm. after this, the Amplatzer device was advanced and during deployment there was embolization into the pulmonary artery. After this, multiple attempts were made at device extraction using multiple catheters. The jr-4 guide, the multipurpose guide, a left internal mammary artery guide, were the catheters that were utilized. Using multiple steering devices such as the 6 French and snare 7 French, an RV biopsy forceps and vascular retrieval forceps and other devices from endoscopy the device was pulled back into the common illiac. After this, the 9 French sheath was exchanged for a 14 French sheath and further attempts made, however, the device could not be retrieved and
vascular surgery was contacted for surgical removal of the device from the right common iliac vein.
AGA MEDICAL CORPORATION/AMPLATZER Model: 9-ASD-010 Lot: M07D24-44 A 10-MM Amplatzer septal occluder was selected; however, the device was malformed on delivery and removed without consequences. Attempts at reconfiguring the device were unsuccessful, and it was felt to be related to a manufacturer's abnormality.
AGA MEDICAL CORPORATION/AMPLATZER Model: 9-ASD-016 Lot: MO7J26-19Difficulty loading a16 mm device into an 8 fr. delivery sheath. We changed to a 9 fr. delivery system. The device loaded appropriately, appeared normal going through the sheath but had a cobra like appearance when released into the atrium. The device retracted into the sheath and was removed from the patient without harm. The device was given to the manufacturer.
AGA MEDICAL CORPORATION/AMPLATZER Lot: MO7K23-08ASD closure device appeared to be seated well on the rims with ice and was deployed. The device migrated to the left ventricle, then to the aortic arch. The device was retrieved to the level of the iliacs in the aorta. Patient was then taken to the operating room for extraction of the device by vascular surgery. Patient tolerated the procedure without complications. Patient will need to be rescheduled for closure of ASD.
W.L. GORE AND ASSOCIATES, INC./ HELEX Catalog: HX1525The patient underwent an implantation of a gore helex septal occluder device to close a patent foramen ovale. Several days later, the patient developed an exertional dyspnea after lifting her child from a stroller. Evaluation in the cardiac services clinic and in radiology revealed embolization of the device from the atrial septum to the abdominal aorta. The patient had the device successfully removed from the aorta seven days after the implant.


Summary of MedSun Reports Describing Adverse Events Involving Burns or Fires during Surgery in the Head and Neck Area

The purpose of providing this summary, and the following reports, is to inform you about problems reported to FDA by the MedSun clinical community. These, as well as non-MedSun reported problems involving this device may also be investigated by searching FDA’s on-line MAUDE database http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm.


Over the past 2 years, MedSun has received 8 adverse event reports involving fires or burns associated with the use of ESU, laser or cautery devices during surgery in the head or neck area. The proximity of the procedures to an oxygen enriched atmosphere is often a contributing factor to these occurrences. The reports were submitted by 8 different hospitals between December, 2006 and January, 2008. The surgical procedures represented in these reports were:

• 4 tonsillectomy and/or adenoidectomy procedures
• 2 tracheotomy procedures
• 1 laser procedure in the patient’s lung
• 1 surgery to remove lipoma on the neck

No reports involved a patient death. The patient injuries listed below were reported in 4 of these 8 reports. In the other reports, prompt intervention by the clinicians appears to have prevented a patient injury.
• 1st and 2nd degree burn – procedure aborted
• Minor burn in mouth - tonsillectomy
• Patient, bronchoscope, laser fiber and trach tube showed evidence of a burn.
• Patient’s chest hair was singed – no apparent burn
• 2nd degree burn to trachea and bronchi

Of the reports that listed patient age, 4 had a patient age listed as less than 21 years and 3 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 4 reports involved female patients and a total of 3 reports involved male patients.

These MedSun reports contribute to FDA’s post-market experience and understanding of problems associated with the use of these devices.


BURNS OR FIRE DURING ESU / LASER PROCEDURES OF THE HEAD OR NECK
Device Device Identifiers Event Description
Electrosurgical Pencil (Covidien Valleylab) E2450HN5B (part of kit) While undergoing excision of lipoma of neck, the surgeon used an electrosurgical pencil to cauterize a bleeder. The pencil was noted to be arcing. Immediately thereafter, fire was observed under the drape.
Electrosurgical Pencil (Covidien Valleylab), Electrode, ESU, bipolar forceps (Covidien Valleylab), Electrode, ESU, bipolar forceps (Aesculap), Generator, ESU, Argon beam (Conmed Electrosurgery)various This incident was reported to me from nurse manager, circulator, and scrub person. Patient status post tonsillectomy bleed. The surgeon was using both a bipolar and a monopolar cautery on the case. The Valleylab bipolar forceps were used as a retractor to expose behind the base of the tongue. It was not attached to the cautery machine. The Aesculap bipolar forceps and the Valleylab suction coagulator E2505-10F were used to resect the uvula and cauterize the tonsillar fossa. The surgeon stated the only explanation he could give for the source of the burn was current flow to the retraction forceps. He stated that the area that was cauterized was always in his direct view, and no arcing or sparking was noted.
Laser System (Laserscope) Model 813 KTP 100W YAG, DP with 630 dye ModuleDoctor was performing laser surgery in patient lungs in an oxygen enriched environment, which resulted in burns to the patient as well as the bronchoscope, laser fiber, and tracheal tube.
Electrosurgical Pencil (ConMed Electrosurgery) Conmed Hand Control with UltraClean, Catalog 131309 When using cautery in the mouth during a tonsillectomy and adenoidectomy (T&A) procedure, the doctor reported a flash (fire). The bovie tip and the tonsil sponge were immediately removed from the mouth. The sponge showed some evidence of a burn. Evaluation revealed the mouth and airway did not seemingly suffer any burns as a result of this incident.
Ablation wand, ENT (Arthrocare Corporation) ArthroCare ENT CoblatorDuring tonsil/adenoid surgery, coblator stopped working properly; smoke coming from tip of probe. MD unable to clear tissue. Used second device, and it worked properly.
Generator, ESU (Covidien Valleylab) Model Unknown During a tracheotomy the patient's O2 saturation began to drop. This required an increase in oxygen to 100%. This caused spillage of oxygen out of the mouth into the area of the wound. There was a short flash of fire on the chest secondary to electrocautery. The fire was put out with sterile water. The patient's chest hair was singed. No apparent burn.
Electrode, ESU, suction coagulator (Covidien Valleylab) Model: E2505-10FRWhile the surgeon was cauterizing the adenoids, the oral cavity caught fire. Saline solution was poured into the mouth. There was no injury to the patient.
Generator, ESU (Covidien Valleylab) Brand: Force FX A spark was noted at the time of the tracheotomy at the insertion site, while a bleeder was being cauterized. Oxygenation was stopped immediately, the endotracheal tube removed, and a tracheal tube inserted. The trachea was flushed with normal saline, cleaned and suctioned. A fiber-optic evaluation of the trachea and bronchi was done, which revealed a possible second degree burn.

Additional Information:

MAUDE - Manufacturer and User Facility Device Experience
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun