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

Model Number 9-VSDMPIHDE-016

Device Problem No Apparent Adverse Event (3189)

Patient Problem Pericardial Effusion (3271)

Event Date 10/15/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.

Event Description

Post infarct vsd closure procedure.Occluder 9-vsdmpihde-016 was placed successfully.Additional left to right flow was noted adjacent to the occluder.An attempt was then made to pass a wire through the secondary defect next to the occluder.While making the attempt a wire and 6fr multipurpose catheter were noted to pass through the border of the heart on x-ray.At that point an effusion and was noted and perforation through the apex of the heart was apparent.An 8mm 9-avp4-008 was then deployed through the mp catheter to and protamine was given to seal the leak.A drain was placed to eliminate the effusion.The procedure was stopped at that point.On (b)(6) 2020 the patient was taken to the or to surgically repair the remaining defect and replace the mitral valve.The 16mm occluder was well seated and left in the heart and the adjacent defect was patched.The patient is stable.

Manufacturer Narrative

An event of pericardial effusion and perforation was reported.A more comprehensive assessment could not be performed as the device remains implanted 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.An initial review of complaints data was reviewed on (b)(6) 2020 as a component of the complaint handling risk review per wi 90591806.Without an identified medical device problem, the aho codes are consistent with the hazards/harms identified for this product family, and no new hazards or harms were identified.

• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10857661
• MDR Text Key: 216844068
• Report Number: 2135147-2020-00484
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• PMA/PMN Number: H070005
• 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: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-VSDMPIHDE-016
• Device Lot Number: 7198464
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention