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

Model Number GSX0030A

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 04/04/2022

Event Type  Injury  

Manufacturer Narrative

The device was discarded at the facility; however, device pictures and a video of the device on the back table were provided for analysis.The images provided confirm the physician¿s observation that the left disc formed as two separate discs.The evaluation also determined that after deployment the right disc is larger than the left and that the right disc also forms two discs.The occluder was difficult to position due to the left and right discs each forming as two separate discs during deployment.This occluder appearance during deployment is caused by a radial shift or clocking of the occluder on the locking mandrel.Based on the evidence provided, the exact cause of the occluder clocking leading to each disc forming as two separate discs during deployment cannot be determined.The cause of the pericardial effusion cannot be determined from the information provided.The gore® cardioform septal occluder instruction for use list significant pleural or pericardial effusion requiring drainage as a potential device- or procedure-related adverse event.

Event Description

It was reported the physician selected a 30mm gore® cardioform septal occluder to treat a patent foramen ovale.The device prepped without issue.While deploying the occluder, the physician noted the left disc appeared to form as two small separate discs.There did not appear to be anatomical obstructions, so the physician removed the device.The device deployed the same way on the back table.At this point, a second 30mm gore® cardioform septal occluder was prepped and deployed without issue.Following device locking, the patient's heart rate dropped and atropine was administered.While further assessing the device the patient's blood pressure dropped.The physician ordered a transesophageal echocardiogram which confirmed a pericardial effusion.Pericardiocentesis was performed, following which the patient was stable.

• 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
• 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: 14208629
• MDR Text Key: 290075548
• Report Number: 2017233-2022-02886
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132631032
• UDI-Public: 00733132631032
• 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
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2023
• Device Model Number: GSX0030A
• Device Catalogue Number: GSX0030A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• Date Device Manufactured: 03/10/2021
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 79 KG