MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM; TRANSCATHETER SEPTAL OCCLUDER

Model Number	MF SEPTAL OCCLUDER CRIBRIFORM
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Embolism/Embolus (4438)
Date of Event	03/14/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2022, a 35mm amplatzer cribriform occluder (7973668) was implanted into a ventricular septal defect (vsd) and released from the delivery cable.It was determined by transesophageal echocardiography (tee) color doppler that there was still a leak present.The delivery system was advanced through the leak, and the occluder dislodged and embolized as the delivery system was being advanced.The device traveled to the patient's left ventricle (lv).A 20mm gooseneck snare was opened and advanced into the lv.After trying to snare the device a couple times, the patient's condition worsened, so retrieval of the device was abandoned.A 35mm amplatzer cribriform occluder (7098008) was loaded onto the cable and was attempted to close the defect, but it was determined to be too small.This device was removed from the patient prior to release from the delivery cable.The patient experienced cardiac tamponade and died on (b)(6) 2022.It was thought that the death was due to a combination of the procedure and the patient's comorbidities.Prior to procedure, the patient had a post-myocardial infarction ventricular septal defect and was intubated in the intensive care unit (icu).This event is being conservatively reported for death.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of device migration, cardiac tamponade, and patient death was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from the field indicated that the physician did not believe the device contributed to the patient's death, and the physician thought that the death was due to a combination of the procedure and the patient's comorbidities.There is no indication of a product quality issue with regards to manufacture design or labeling.Please note, per the instructions for use, the amplatzer¿ cribriform occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the closure of "multi-fenestrated" (cribriform) atrial septal defects (asd).
Event or Problem Description
Subsequent to the initially filed information, it was reported that the delivery system was an amplatzer torqvue delivery system.After the first device was placed in the defect, there was still a significant leak present.The physician tried to cross the defect with the delivery system to place a second device in the defect.While trying to cross the defect with the delivery system, the first device dislodged.

• Brand Name: AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14073429
• Report Number: 2135147-2022-00147
• Device Sequence Number: 20347913
• Product Code: MLV
• UDI-Device Identifier: 00811806010311
• UDI-Public: 00811806010311
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: MF SEPTAL OCCLUDER CRIBRIFORM
• Device Catalogue Number: 9-ASD-MF-035
• Device Lot Number: 7973668
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER TORQVUE DELIVERY SYSTEM.; DELIVERY SYSTEM (UNKNOWN MANUFACTURER).
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown