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

Catalog Number GSX0030A

Device Problems Break (1069); Entrapment of Device (1212); Mechanical Jam (2983)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/21/2018

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.The occluder and delivery catheter were returned to gore for analysis.The investigation revealed that the delivery system was kinked and damaged at the guidewire port.The occluder lodging in the delivery catheter may have contributed to the deformation at the guidewire port and retrieval cord break.The size and shape of the occluder and lock loop were unremarkable.The cause of the control shuttle and occluder reportedly becoming stuck is unknown and cannot be determined from the evidence available.Digital cine fluoroscopy runs were received for evaluation.The imaging shows that the device appears to be partially retrieved with the retrieval cord system.The right disc is inside of the delivery catheter, the central eyelet is located at the tip of the delivery catheter, and the left disc is still formed outside of the catheter.It is unclear from the imaging provided why the retrieval cord broke.Without echocardiography imaging it cannot be determined if anatomy played a role.The delivery catheter does appear to be at an angle distally; pulling down on the entire system to straighten the catheter may have allowed the device to be removed.(b)(4).

Event Description

It was reported the physician selected a 30mm gore® cardioform septal occluder to close an atrial septal defect balloon sized to 16mm x 17mm.Following device locking, the occluder prolapsed into the right atrium and was removed without issue.A second 30mm gore® cardioform septal occluder was prepared and advanced to the defect.The left disc was deployed; however, while beginning to deploy the right disc the deployment slider became stuck, and wouldn't move in either direction.At this point, the physician opted to attempt device removal with the retrieval cord.The device became lodged in the delivery catheter and the retrieval cord broke.After a couple of unsuccessful attempts to remove the device by other means, including forceps, a decision was made to cap the sheath and send the patient to surgery.During surgery the device was removed and the defect was closed.The patient was doing well following the procedure.

Manufacturer Narrative

The correct product udi is: (b)(4).

• Brand Name: GORE® CARDIOFORM SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7435056
• MDR Text Key: 105635021
• Report Number: 2017233-2018-00220
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2020
• Device Catalogue Number: GSX0030A
• Device Lot Number: 17763066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 8 YR
• Patient Weight: 26