MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number	9-ASD-038
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Related manufacturing reference number: 2135147-2021-00132 on (b)(6) 2021, after baloon sizing at 34mm with little aortic rim, a 38mm amplatzer septal occluder(lot#5612973) was selected for implant in the patient using an amplatzer torqvue delivery system(lot#7302272).During the procedure the device deployed into a cobra shape.The device was removed from the patient and exchanged for a new 38mm amplatzer septal occluder(lot#6330319).Using the same delivery system, the 38mm device was deployed in the patient, but was missized too large.The device and delivery system were removed from the patient and exchanged for a 32mm amplatzer septal occluder(lot#6140846) and a new amplatzer torqvue delivery system(lot#707244).The device deployed in the patient in a cobra shape and the physician exchanged the device for a new 32mm amplatzer septal occluder(lot# 5933064).Using the same delivery system, the device was deployed with good results in the patient and was released.There was a clinically significant delay in the procedure, but the patient remained hemodynamically stable during the procedure with no adverse events.The patient is currently discharged and stable.
Additional Manufacturer Narrative
Additional information for: g3, g6, h2, h6, and h10 an event of device deformity was reported.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.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11632064
• Report Number: 2135147-2021-00131
• Device Sequence Number: 19707810
• Product Code: MLV
• UDI-Device Identifier: 00811806010267
• UDI-Public: 00811806010267
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 9-ASD-038
• Device Catalogue Number: 9-ASD-038
• Device Lot Number: 5612973
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 05/16/2021
• 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: 32MM AMPLATZER SEPTAL OCCLUDER
• Outcome Attributed to Adverse Event: Required Intervention