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

Model Number	9-PFO-3525
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2023, a 35-25mm amplatzer talisman patent foramen ovale (pfo) occluder was selected for procedure.It was noted during device preparation that there had been difficulty experienced obtaining blood backflow through the loader.It was also noted during procedure that the right atrial disc of the occluder exhibited a bulbous deformation while being deployed.The decision was made to remove and replaced the 35-25mm amplatzer talisman (pfo) occluder with a 30-25mm amplatzer talisman (pfo) occluder to complete the procedure.There were no adverse patient consequences reported.The patient was stable at the time of report.No additional information was provided.
Additional Manufacturer Narrative
An event of device deformity could not be confirmed.Images were received from the field and the images appeared to show the device deforming bulbous, however, the device was returned to abbott for investigation and the device met functional specifications when analyzed 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.Information from the field indicated that there was no anatomical interference or any angulation or kink in the delivery system upon deployment and 9f size delivery system was used.The cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
Subsequent to the previously filed report, additional information was received: the talisman 9f sheath was positioned in the left atrium.The loader was connected to the sheath, and the physician complained that there was no back bleeding in the loader, perhaps because of the device obstructing the lumen of the loader.The 9f talisman delivery sheath was exchanged for a new one of the same size.It was also noted during procedure that the right atrial disc of the occluder exhibited a bulbous deformation while being deployed.The occluder was never released from the cable, there were no interactions with cardiac structures during deployment, and there was no kink observed with the delivery sheath.The occluder was removed from the patient and tested; the deformation persisted.In addition to the 30-25mm amplatzer talisman occluder, a noble stitch was performed.The patient remained hemodynamically stable throughout the procedure and no clinically significant delay was reported.The patient was discharged in stable condition.

• Brand Name: AMPLATZER TALISMAN PFO OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16308234
• Report Number: 2135147-2023-00408
• Device Sequence Number: 6802964
• Product Code: MLV
• UDI-Device Identifier: 05415067033345
• UDI-Public: 05415067033345
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P120021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2023

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: 05/31/2025
• Device Model Number: 9-PFO-3525
• Device Catalogue Number: 9-PFO-3525
• Device Lot Number: 8542130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Unknown