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

Model Number 9-ASD-018

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2020, an 18mm amplatzer septal occluder was selected for implant.During preparation, the physician observed exposed threads outside the left sided disc and decided to implant a new device.The event led to a clinically significant delay in the procedure, but the patient was reported to be stable.

Manufacturer Narrative

Additional information: d10, g$, h2, h3, h6 & h10.The reported event of an amplatzer septal occluder with exposed threads outside the left disc could not be confirmed.A more comprehensive assessment could not be performed as 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.Based on the information received, the cause of the reported incident could not be conclusively determined.A capa was initiated for further investigation on the protruding threads, per internal procedures.

• 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: 10277440
• MDR Text Key: 199673923
• Report Number: 2135147-2020-00318
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010151
• UDI-Public: 00811806010151
• 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
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-ASD-018
• Device Catalogue Number: 9-ASD-018
• Device Lot Number: 7137133
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 09/23/2020
• Supplement Dates FDA Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1