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

Model Number	9-PFO-3525
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022, a 35-25mm amplatzer talisman patent foramen ovale (pfo) occluder was selected for procedure using a 9f talisman delivery sheath.It was noted that during procedure the right atrial disc of the occluder exhibited a bulbous shape when being deployed.The occluder was never released from the cable and there were no interactions with cardiac structures.No angulation/kink was observed with the delivery system.The decision was made to fully recapture and remove the occluder from the patient and attempt to fix the occluder.After an unsuccessful attempt to fix the occluder, the decision was made to replace the 35-25mm amplatzer talisman (pfo) occluder with an unknown 25mm replacement device to complete the procedure.There were no adverse patient effects reported.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of the device deformation was reported.A returned device 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 defined manufacturing specifications.Based on the information received, 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 reported, additional information was received that a 9f amplatzer talisman delivery sheath had been used when attempting to implant the deformed 35-25mm amplatzer talisman patent foramen ovale (pfo) occluder.It was confirmed via angiography and transesophageal echocardiography exams that the 35-25mm amplatzer talisman (pfo) occluder had exhibited a bulbous shaped deformation of the right atrial disc.The deformed occluder was never released from the delivery cable while inside the patient.There was no angulation or kink noted in the delivery system and no interaction with cardiac structures during deployment.The 35-25mm amplatzer talisman (pfo) occluder had been sized according to the instructions for use.The 35-25mm amplatzer talisman pfo occluder was properly prepared according to the instruction for use.The occluder was rotated counter-clockwise 1/8 of one turn to facilitate device release upon deployment.The replacement device that was successfully implanted to complete the procedure was a 30-25mm amplatzer talisman patent foramen ovale (pfo) occluder.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects reported.No additional information was provided.

• 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: 15396124
• Report Number: 2135147-2022-01086
• Device Sequence Number: 14726953
• Product Code: MLV
• UDI-Device Identifier: 05415067033345
• UDI-Public: 05415067033345
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P120021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 11/17/2022

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: 10/31/2024
• Device Model Number: 9-PFO-3525
• Device Catalogue Number: 9-PFO-3525
• Device Lot Number: 8213789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2021
• 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: 59 YR
• Patient Sex: Male