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

Model Number	9-ASD-013
Medical Device Problem Codes	Off-Label Use (1494); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.
Event or Problem 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).
Additional 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
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10842830
• Report Number: 2135147-2020-00478
• Device Sequence Number: 14327955
• Product Code: MLV
• UDI-Device Identifier: 00811806010106
• UDI-Public: 00811806010106
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2020

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?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 9-ASD-012; 9-ASD-014
• Outcome Attributed to Adverse Event: Hospitalization