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

Model Number	9-ASD-038
Medical Device Problem Codes	Off-Label Use (1494); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event of device deformation could not be confirmed.The investigation confirmed the device met visual and functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported incident could not be conclusively determined.Please note, per instruction for use, arten600038247 - a, "the amplatzer¿ septal occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the occlusion of atrial septal defects (asd) in secundum position or patients who have undergone a fenestrated fontan procedure and who now require closure of the fenestration.".
Event or Problem Description
It was reported that on (b)(6) 2021, a 24mm amplatzer post-infarct muscular vsd occluder was selected for implant, however the device was mis-sized too small and removed while still attached to the delivery cable.Then, a 32mm amplatzer septal occluder was attempted; which was also mis-sized and removed while still attached to the delivery cable.In the process of re-crossing the ventricular septal defect (vsd), the 12f amplatzer torqvue delivery system developed a kink due to tortuous patient anatomy and was exchanged for a new 12f amplatzer torqvue delivery system.Then, a 28mm amplatzer septal occluder was attempted, however the device deformed with a cobra head and was removed while still attached to the delivery cable.During another attempt at crossing the vsd, an unknown manufacturer guide wire perforated the right ventricle, resulting in pericardial effusion and hemodynamic instability.The patient passed away due to perforation of the right ventricle.The patient's death is not related to an abbott device, but a non-abbott guidewire used during the procedure.Not additional information was provided.

• 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: 12714448
• Report Number: 2135147-2021-00459
• Device Sequence Number: 17203299
• Product Code: MLV
• UDI-Device Identifier: 00811806010267
• UDI-Public: 00811806010267
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/28/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 9-ASD-038
• Device Catalogue Number: 9-ASD-038
• Device Lot Number: 6661666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR