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

Model Number GSX0030A

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2020

Event Type  malfunction  

Event Description

It was reported the physician was implanting a 30mm gore® cardioform septal occluder to close a patent foramen ovale.The physician attempted multiple times to cross the pfo with no success.They could not get the delivery catheter to cross the pfo over the guide wire.While attempting to remove the delivery catheter, it got stuck on the tip of the avanti 11fr introducer sheath.More force was applied, and the delivery catheter was removed.Upon inspection of the removed catheter it was noted that the radiopaque marker and guidewire port were missing from the tip of the delivery catheter.It was still on the guidewire just outside the tip of the introducer sheath.A balloon and larger sheath were used to remove the tip of the catheter without incident.A new 30mm device was implanted with no issues.The patient was doing well following the procedure.

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.

Manufacturer Narrative

The engineering investigation stated the following: the investigation revealed that a separation of the delivery catheter occurred near the distal end of the guidewire port.Inward deformation of the edges of the guidewire port and evidence of necking of the delivery catheter materials near the break are consistent with the application of significant tension along the length of the delivery catheter.The separated tip of the delivery catheter showed unraveling of the braid, frayed layers of the catheter and outward deformation of the distal edge of the guidewire port.The investigation also revealed that all other delivery system components including the sliding and locking mechanisms were unremarkable and that the size and shape of the occluder and lock loop were unremarkable.The findings of the investigation are consistent with the reporting of the event in that the delivery catheter was broken in tension, possibly due to interference between the tip of the delivery catheter and the 11fr avanti sheath (with possible guidewire involvement).However, the root cause of that interaction cannot be determined from the evidence available.Based on the visual examination of the delivery catheter, there is no indication that the reported events listed above were due to design or manufacture of the device.

• Brand Name: GORE CARDIOFORM SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10741522
• MDR Text Key: 213242040
• Report Number: 2017233-2020-01383
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132631032
• UDI-Public: 00733132631032
• 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,Followup
• Report Date: 12/15/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2022
• Device Model Number: GSX0030A
• Device Catalogue Number: GSX0030A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 10/01/2020; 10/01/2020
• Supplement Dates FDA Received: 11/04/2020; 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 76