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

Model Number	PFO OCCLUDER
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2023
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 18 february 2023, an 18mm amplatzer patent foramen ovale (pfo) occluder was selected for implant using an 8f amplatzer trevisio intravascular delivery system.It was noted during procedure that it appeared as though a thrombus had adhered to the occluder.The occluder was fully removed and it was determined that an exposed thread was coming out of the occluder.The 18mm amplatzer patent foramen ovale (pfo) occluder was not damaged or mishandled at any point during device preparation.The occluder had been sized using an unknown 24mm sizing balloon.There was no thrombus confirmed.The patient does not have any hematologic disorders or systemic illness that could contribute to a hypercoagulability.The patient receive any treatment (medications) that could contribute to thrombus formation.It was noted that the occluder was retracted fully/completely into the delivery system prior to noting the exposed thread.The decision was made to 18mm amplatzer patent foramen ovale (pfo) occluder with another one of the same size to complete the procedure.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects reported.The patient was discharged at the time of report.No additional information was provided.
Additional Manufacturer Narrative
An event of a protruding polyester thread 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 specifications.One image from field appeard to show that thread was hanging from nithinol mesh.Based on the information received, the cause of the reported incident could not be conclusively determined.
Additional Manufacturer Narrative
Additional information: d9, g3, g6, h2, h3, h6, h10 the reported event of a protruding polyester thread was confirmed, a sewing knot was preset on the proximal disc of device.However this knot met dimensional specifications when analyzed at abbott.The sewing knots that are seen above the nitinol wires are considered a normal and acceptable characteristic of the occluder and are a result of the manufacturing process.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.
Event or Problem Description
It was reported that on (b)(6) 2023, an 18mm amplatzer patent foramen ovale (pfo) occluder was selected for implant using an 8f amplatzer trevisio intravascular delivery system.It was noted during procedure that it appeared as though a thrombus had adhered to the occluder.The occluder was fully removed and it was determined that an exposed thread was coming out of the occluder.The 18mm amplatzer patent foramen ovale (pfo) occluder was not damaged or mishandled at any point during device preparation.The occluder had been sized using an unknown 24mm sizing balloon.There was no thrombus confirmed.The patient does not have any hematologic disorders or systemic illness that could contribute to a hypercoagulability.The patient receive any treatment (medications) that could contribute to thrombus formation.It was noted that the occluder was retracted fully/completely into the delivery system prior to noting the exposed thread.The decision was made to 18mm amplatzer patent foramen ovale (pfo) occluder with another one of the same size to complete the procedure.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects reported.The patient was discharged at the time of report.

• Brand Name: AMPLATZER 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: 16548213
• Report Number: 2135147-2023-01204
• Device Sequence Number: 20399368
• Product Code: MLV
• UDI-Device Identifier: 00811806011271
• UDI-Public: 00811806011271
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 08/28/2023

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: 05/31/2024
• Device Model Number: PFO OCCLUDER
• Device Catalogue Number: 9-PFO-018
• Device Lot Number: 7039716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 05/05/2023; 08/04/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 05/19/2023; 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2019
• 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: 49 YR
• Patient Sex: Female