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

Model Number ASD37A

Device Problems Break (1069); Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923)

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

Event Date 12/20/2021

Event Type  Injury  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 287792449
• Report Number: 2017233-2022-02664
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132636501
• UDI-Public: 00733132636501
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 01/12/2022
• Supplement Dates Manufacturer Received: 12/20/2021; 12/20/2021
• Supplement Dates FDA Received: 02/17/2022; 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR
• Patient Sex: Female
• Patient Weight: 38 KG