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

Model Number 9-PFO-030

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2021

Event Type  malfunction  

Event Description

It was reported that a 30mm amplatzer pfo occluder was selected for an implant on (b)(6) 2021.During deployment device appeared bulbous in shape.A second 30mm amplatzer pfo occluder was deployed but also appear bulbous in shape.There was no interaction with atrial structures during deployment and no angulation or kink noticed in the delivery system.Device was removed from the patient prior to release from the delivery cable.A third 30mm amplatzer pfo occluder was selected and implanted with no patient harm.No additional information was provided.

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

T was reported that a 30mm amplatzer pfo occluder was selected for an implant on (b)(6) 2021.During deployment device appeared bulbous in shape.A second 30mm amplatzer pfo occluder was deployed but also appear bulbous in shape.There was no interaction with atrial structures during deployment and no angulation or kink noticed in the delivery system.Device was removed from the patient prior to release from the delivery cable.A third 30mm amplatzer pfo occluder was selected and implanted with no patient harm.No additional information was provided.Related manufacturer report number- 2135147-2021-00553.

Manufacturer Narrative

The reported event of device deformity 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.

• Brand Name: AMPLATZER PFO OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13075111
• MDR Text Key: 282775755
• Report Number: 2135147-2021-00552
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-PFO-030
• Device Lot Number: 7704857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1