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

Model Number	9-ASD-MF-018
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
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
It was reported that on (b)(6) 2021, a 18 mm amplatzer cribriform occluder was selected for implant.During the implant procedure, while deploying the device, it was unable to deploy in the desired shape.No additional information was provided.
Additional Manufacturer Narrative
An event of the device being unable to deploy in the desired shape 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.
Additional Manufacturer Narrative
Additional information: b5.
Event or Problem Description
Additional information received indicates that the devices distal disc pretend in a bulbous deformation during deployment.The device was removed and replaced with a non-abbott device to resolve the event.Dek.
Event or Problem Description
Additional information received indicating that a 9f non-abbott delivery system was used for the implant procedure.The delivery system was 1 size larger than is recommended.
Additional Manufacturer Narrative
An event of "the distal disc deployed in a bulbous deformation" was reported.The investigation confirmed the device met functional specifications when analyzed at abbott under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.The cause of the reported event could not be conclusively determined.

• Brand Name: AMPLATZER CRIBRIFORM OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12233121
• Report Number: 2135147-2021-00299
• Device Sequence Number: 3532687
• Product Code: MLV
• UDI-Device Identifier: 00811806010281
• UDI-Public: 00811806010281
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup,Followup,Followup
• Report Date (Section B): 10/19/2021

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: 09/30/2021
• Device Model Number: 9-ASD-MF-018
• Device Catalogue Number: 9-ASD-MF-018
• Device Lot Number: 5673105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 08/18/2021; 09/09/2021; 09/29/2021; 10/19/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 08/30/2021; 09/14/2021; 10/08/2021; 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1