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

Catalog Number GSX0025A

Device Problem Difficult to Advance (2920)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Perforation (2001)

Event Date 11/18/2019

Event Type  Injury  

Manufacturer Narrative

Additional devices used in this procedure: gsx0025a/21221028 udi (01) (b)(4), (17) (b)(4), (21 )(b)(4), and gsx0030a/20820609 udi (01) (b)(4), (17) (b)(4), (21) (b)(4).

Event Description

It was reported the physician selected a 25mm gore® cardioform septal occluder to close a patent foramen ovale.The physician experienced advancement issues in the femoral artery after the delivery system exited the 11fr.Terumo introducer sheath.Fluoroscopy showed the catheter appeared to be bent back on itself.The device was removed and checked on the back table.The delivery catheter was kinked and the physician chose not to attempt reinserting the device.A second 25mm gore® cardioform septal occluder was advanced and deployed without difficulty; however, when the retrieval cord was being removed, the right eyelet was pulled off the lock loop and the device was removed with a snare.During this time the patient became hypotensive and bradycardic.The patient was treated with atropine and neosynephrine.A 30mm gore® cardioform septal occluder was then selected and deployed.During deployment the patient again became hypotensive and bradycardic and was treated with atropine and neosynephrine.The device was locked, but upon retrieval cord removal, the right eyelet was pulled off the lock loop.The device was removed with the retrieval cord.Intracardiac echocardiography and transesophageal echocardiography were performed to see if the patient had suffered a pericardial effusion.Imaging did not confirm an effusion, and the physician performed a venogram.The venogram showed a femoral artery perforation which was treated with a covered stent.The procedure was concluded without defect closure and the patient remained stable.

Manufacturer Narrative

The gore® cardioform septal occluder instructions for use list access site complications requiring an interventional procedure and perforation or damage of a cardiovascular structure by the device as potential device or procedure related adverse events.

• Brand Name: GORE® CARDIOFORM SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9467505
• MDR Text Key: 185072638
• Report Number: 2017233-2019-01247
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132631025
• UDI-Public: 00733132631025
• 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: 12/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: GSX0025A
• Device Lot Number: 21030890
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 69 YR