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

Catalog Number	9-PFO-035
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	01/22/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical information: (b)(6) - pfo japan pas, patient site id: (b)(6).It was reported that on (b)(6) 2020, a 35mm amplatzer patent foramen ovale (pfo) occluder and 10f amplatzer torqvue delivery system were selected for procedure.The patient was consciously sedated for procedure.The patient was administered 8000 units of heparin for procedure.It was noted during procedure using unknown imaging, that there was a thrombus noted within the 10f delivery system, adhering the disc of the occluder.The decision was made to remove the 10f amplatzer torqvue delivery system and 35mm amplatzer (pfo) occluder and replace them.A replacement 35mm amplatzer (pfo) occluder was prepared and successfully implanted.There is no allegation of malfunction against the abbott device or procedure.The patient was stable at the time of report.
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 patient device interaction problem associated with thrombus 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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the information received, a root cause of the reported patient device interaction problem and patient effect thrombus could not be conclusively determined.The reported serious injure/illness/impairment was a result of case-specific circumstances.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.
Event or Problem Description
Clinical information: crd_961 - pfo japan pas, patient site id: (b)(6).

• Brand Name: AMPLATZER PFO OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19960701
• Report Number: 2135147-2024-03913
• Device Sequence Number: 15641404
• Product Code: MLV
• UDI-Device Identifier: 00811806011301
• UDI-Public: (01)00811806011301(17)240831(10)7162167
• 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: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Catalogue Number: 9-PFO-035
• Device Lot Number: 7162167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER TORQVUE DS, 9-ITV10F45/80 (LOT: 6960433)
• Patient Sex: Unknown