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

Model Number	9-ASD-MF-035
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Off-Label Use (1494)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	02/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
In 2013 transesophageal echocardiogram (toe) imaging was done and it revealed a patent foramen ovale (pfo).On (b)(6) 2020, imaging during the intervention was intra-cardiac echocardiography (viewflex catheter) and a 35mm amplatzer cribriform occluder was selected and successfully implanted in the patient.Three months post-procedure, the patient had an echo follow up and the physician discovered the device had embolized into the left ventricular outflow.The patient was asymptomatic.On (b)(6) 2021.The patient had a surgical intervention to remove the amplatzer cribriform occluder.No other device was implanted and the patient is currently stable.
Additional Manufacturer Narrative
An event of off-label use of the device and device embolism was reported.A more comprehensive 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.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note, per the instructions for use, artmt600034247 revision b "the amplatzer¿ cribriform occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the closure of multi-fenestrated (cribriform) atrial septal defects." and "contraindications: treatment of patients with patent foramen ovale (pfo) defects.This device has not been studied in patients with pfo defects.".

• Brand Name: AMPLATZER CRIBRIFORM OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11520514
• Report Number: 2135147-2021-00099
• Device Sequence Number: 11620715
• Product Code: MLV
• UDI-Device Identifier: 00811806010311
• UDI-Public: 00811806010311
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: 9-ASD-MF-035
• Device Catalogue Number: 9-ASD-MF-035
• Device Lot Number: 7385218
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention