MAUDE Adverse Event Report: AGA MEDICAL CORPORATION; AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER

Model Number 9-VSDMPIHDE-022

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2019

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.

Event Description

On (b)(6) 2019, a 22mm amplatzer post-infarct muscular vsd occluder was selected to close a post-infarct vsd.The device was reported to have deployed in a "cobra" formation and was exchanged for another 22mm amplatzer post-infarct muscular vsd occluder.However, the second device also deployed in a "cobra" formation.The physician suspects the deformation was due to an interaction with the icd lead and he elected to deploy an unknown 20mm device far from the icd lead and the procedure was completed successfully with no further issues reported.

Manufacturer Narrative

The reported event of deformity upon deployment could not be confirmed.The investigation confirmed the device met functional specifications when analyzed at abbott under non-physiological conditions.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.The cause of the reported event could not be conclusively determined, however, per the site the physician suspected the deformation was due to an interaction with the icd lead.

Event Description

On (b)(6) 2019, a 22mm amplatzer post-infarct muscular vsd occluder was selected to close a post-infarct vsd.The device was reported to have deployed in a "cobra" formation and was exchanged for another 22mm amplatzer post-infarct muscular vsd occluder.However, the second device also deployed in a "cobra" formation.The physician suspects the deformation was due to an interaction with the icd lead and he elected to deploy a 20mm amplatzer post-infarct muscular vsd occluder (lot number: 18044472) far from the icd lead and the procedure was completed successfully with no further issues reported.The patient is reported to be stable in the hospital.

• Type of Device: AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8790997
• MDR Text Key: 151111514
• Report Number: 2135147-2019-00211
• Device Sequence Number: 1
• Product Code: OZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-VSDMPIHDE-022
• Device Lot Number: 16708865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention