MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER P.I. MUSCULAR VSD OCCLUDER; CARDIAC OCCLUSION DEVICE

Model Number 9-VSDMUSCPI-018

Device Problem Missing Information (4053)

Patient Problem Death (1802)

Event Date 03/18/2019

Event Type  Death  

Event Description

On (b)(6) 2019, a 18mm vsd musc pi occluder and 20mm vsd music pi occluder was selected for closure of a muscular vsd.During placement, of the 20mm vsd musc pi occluder, the patient became unstable and resuscitation was attempted without success.Additional information has been requested.

Manufacturer Narrative

An unspecified issue and patient death 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 at the time of commercialization.The cause of the reported incident could not be conclusively determined; however, per the site the patient was very unstable due to post infarct vsd.

Event Description

Three weeks prior to this event's procedure, the patient experienced myocardial infarction.On (b)(6) 2019, the patient was very unstable due to the post infarct ventricular septal defect (pi vsd), so a 18mm amplatzer p.I.Muscular vsd occluder (pi mvso) and 20mm pi mvso were selected for use to occlude the pi vsd.The 18mm pi mvso was deployed but resheathed for upsizing.During placement of the 20mm pi mvso, the patient's unstable condition worsened, and resuscitation was attempted unsuccessfully.The patient expired post-procedure on (b)(6) 2019.

• Brand Name: AMPLATZER P.I. MUSCULAR VSD OCCLUDER
• Type of Device: CARDIAC OCCLUSION DEVICE
• 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: 8500109
• MDR Text Key: 141491384
• Report Number: 2135147-2019-00099
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 9-VSDMUSCPI-018
• Device Catalogue Number: 9-VSDMUSCPI-018
• Device Lot Number: 5264452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention