MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® CARDIOFORM ASD OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number	ASD37A
Medical Device Problem Codes	Break (1069); Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the physician selected a 37mm gore® cardioform asd occluder to treat an atrial septal defect.The defect had a static measurement of 14-15mm and was balloon sized to 19mm.The defect measured 20mm with transesophageal echocardiography.Following device placement and locking, a residual shunt was noted.As the physician attempted to retrieve the device, the retrieval cord broke and the device embolized into the right atrium near the tricuspid valve.The physician used a snare to grab the left atrial eyelet.At this point in retrieval, the device extended and the lock loop appeared to pull through the eyelets.The physician then used a larger sheath to retrieve the occluder without issue.A 20mm amplatzer device was then implanted with no adverse effects.The patient was doing well following the procedure.
Additional Manufacturer Narrative
The device was returned to gore for analysis.The investigation revealed that the delivery catheter was kinked at the guidewire port and 11cm from the distal end.The investigation also confirmed a break in the retrieval cord at the distal end of the control catheter.The right atrial eyelet did unravel at the retrieval loop.Per the gore® cardioform asd occluder instructions for use, it is possible that excessive force at retrieval can result in retrieval cord breaks.The presence of the delivery catheter kinks, right eyelet unravel, and the break in the retrieval cord suggest that excessive force was used at retrieval.The cause of the difficulty retrieving the device in unknown and cannot be determined from the evidence available.The snaring process contributed to the left atrial eyelet unravel.The size of the occluder, and the size and shape of the lock loop were unremarkable.All other delivery system components including the sliding and locking mechanisms were unremarkable.
Additional Manufacturer Narrative
One fluoroscopic image was received for analysis.The image revealed a gore® cardioform asd occluder being snared.This image does allow for investigation of the broken retrieval cord and subsequent embolization of the device.

• Brand Name: GORE® CARDIOFORM ASD OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: marci stewart ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13236323
• Report Number: 2017233-2022-02664
• Device Sequence Number: 4280711
• Product Code: MLV
• UDI-Device Identifier: 00733132636501
• UDI-Public: 00733132636501
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P050006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/15/2024
• Device Model Number: ASD37A
• Device Catalogue Number: ASD37A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 12/20/2021; 12/20/2021
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 02/17/2022; 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 6 YR
• Patient Sex: Female
• Patient Weight: 38 KG