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

Model Number 9-ASD-013

Device Problems Off-Label Use (1494); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

An 12mm amplatzer septal occluder device was selected for vsd implant.The user tried a 12mm amplatzer septal occluder(lot no: 6240039),and it formed a shape of a cobra and wouldn't sit appropriately.We decided we would try a 14mm amplatzer septal occluder(lot no: 7266691), that too also formed a shape of a cobra, but in this case after a couple of tries it wouldn't go back to originally shape as good as it should have, the same thing happened with 13mm amplatzer septal occluder (lot no: 6791191).It was decided to try a muscular vsd, therefore we closed the second hole with an avp2.The patient wasn't harmed at during procedure.The case just took a little longer than hoped.Additional reports for 9-asd-014 (mdr-2020-48416), 9-asd-012 (mdr-2020-48413).

Manufacturer Narrative

The reported event of deformation during deployment 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.Please note, per the instructions for use artmt100116885 rev.A, "the amplatzer¿ septal occluder is a percutaneous, transcatheter atrial septal defect closure device intended for the occlusion of atrial septal defects (asds) in secundum position or patients who have undergone a fenestrated fontan procedure and who now require closure of the fenestration." an initial review of complaints data was reviewed on 2020 as a component of the complaint handling risk review per wi 90591806.The medical device problem and aho codes are consistent with the hazards/harms identified for this product family, and no new hazards or harms were identified.

• 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: 10842830
• MDR Text Key: 217705055
• Report Number: 2135147-2020-00478
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010106
• UDI-Public: 00811806010106
• 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: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 9-ASD-013
• Device Catalogue Number: 9-ASD-013
• Device Lot Number: 6791191
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 9-ASD-012; 9-ASD-014
• Patient Outcome(s): Hospitalization