MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-ASD-011

Device Problems Difficult to Remove (1528); Retraction Problem (1536)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2019

Event Type  malfunction  

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.

Event Description

On (b)(6) 2019, a 13mm amplatzer septal occluder (lot number: 6867152) was selected for implant using a 45/80mm 7f torque delivery system in a 10kg child.The device was mis-sized, too large, and exchanged for an 11mm amplatzer septal occluder (lot number: 6851795).During implant, the second device was unable to be placed during the first pass.Subsequently the physician experienced difficulty resheathing the device, only managing to half sheath the device using great force.The partially recaptured device was withdrawn and the procedure was aborted.The tip of the delivery system was observed to have deformed in a concertina after removal from the patient.The procedure was aborted and the patient was referred for surgical closure.No patient consequences were reported.

Manufacturer Narrative

09/13/2019 mjr ¿ supplemental report needed to address analysis: the reported event of difficulty re-sheathing the device could not be confirmed.The results of the investigation are inconclusive since 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 at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.

Manufacturer Narrative

An event of difficulty retracting the device was reported.The investigation confirmed the device met functional and dimensional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported incident could not be conclusively determined.

Event Description

Reference manufacturer report number: 2135147-2019-00200.On (b)(6) 2019, a 13mm amplatzer septal occluder (lot number: 6867152) was selected for implant using a 45/80mm 7f torqvue delivery system in a 10kg child.The device was mis-sized, too large, and exchanged for an 11mm amplatzer septal occluder (lot number: 6851795).During implant, the second device was unable to be placed during the first pass.Subsequently the physician experienced difficulty resheathing the device, only managing to half sheath the device using great force.The partially recaptured device was withdrawn and the procedure was aborted.The tip of the delivery system was observed to have deformed in a concertina after removal from the patient.The procedure was aborted and the patient was referred for surgical closure.No patient consequences were reported.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8840866
• MDR Text Key: 158697744
• Report Number: 2135147-2019-00203
• Device Sequence Number: 1
• Product Code: MLV
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 9-ASD-011
• Device Catalogue Number: 9-ASD-011
• Device Lot Number: 6851795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMPLATZER TORQVUE DELIVERY SYSTEM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 10