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

Model Number 9-ASD-014

Device Problems Human-Device Interface Problem (2949); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2021

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.Medwatch report number: mw5100630.

Event Description

It was reported on (b)(6) 2021, a 14mm amplatzer septal occluder was implanted.The patient was discharged the same day of implant procedure.The patient presented for follow-up in (b)(6) 2021.Am echocardiogram was performed and a small shunt from left to right was noted.A follow-up transesophageal echocardiogram (tee) was performed and noted that the device had migrated.On (b)(6) 2021, the patient was taken to the cath lab and the device was successful retrieved.The patient was reported to be in stable condition.

Manufacturer Narrative

Additional information h6, h10.An event of migration and residual shunt 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.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11863125
• MDR Text Key: 252342521
• Report Number: 2135147-2021-00203
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010113
• UDI-Public: 00811806010113
• Combination Product (y/n): N
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/05/2021,05/27/2021

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
• Device Operator: Health Professional
• Device Model Number: 9-ASD-014
• Device Catalogue Number: 9-ASD-014
• Device Lot Number: 7112165
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 04/05/2021
• Distributor Facility Aware Date: 03/25/2021
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2021
• Initial Date Manufacturer Received: 05/03/2021
• Initial Date FDA Received: 05/21/2021
• Supplement Dates Manufacturer Received: 05/26/2021
• Supplement Dates FDA Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention