MAUDE Adverse Event Report: AGA MEDICAL CORPORATION 9VSDMPIIDE024 PKGD STERILE HDE; AMPLATZER¿ PI MUSCULAR VSD OCCLUDER

Model Number	9-VSDMPIHDE-024
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, a 24mm amplatzer pi muscular vsd occluder was selected for implant to close a post infarct vsd.The patient was hemodynamically unstable and after 2 unsuccessful attempts to deploy the device, as the right disc did not deploy as anticipated; the user elected to abandon the procedure.The user reports the deformation was associated with the patient anatomy.No additional information is anticipated.
Additional Manufacturer Narrative
An event of a deformed right disc was reported.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; however, per the user the deformation was associated with the patient anatomy.
Event or Problem Description
On (b)(6) 2019, a 24mm amplatzer pi muscular vsd occluder was selected for implant to close a post infarct vsd.The patient was hemodynamically unstable and after 2 unsuccessful attempts to deploy the device, as the right disc did not deploy as anticipated; the user elected to abandon the procedure.The user reports the deformation was associated with the patient anatomy.No additional information is anticipated.

• Brand Name: 9VSDMPIIDE024 PKGD STERILE HDE
• Common Device Name: AMPLATZER¿ PI MUSCULAR VSD OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8411901
• Report Number: 2135147-2019-00052
• Device Sequence Number: 16657008
• Product Code: MLV
• UDI-Device Identifier: 05415067028143
• UDI-Public: 05415067028143
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2019

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: 02/28/2022
• Device Model Number: 9-VSDMPIHDE-024
• Device Lot Number: 5918983
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 06/11/2019
• 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