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

Catalog Number GSX0025A

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Chest Pain (1776); Pericardial Effusion (3271)

Event Date 06/15/2016

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.(b)(4).

Event Description

It was reported the physician selected a 30mm gore cardioform septal occluder to close a patent foramen ovale.The physician experienced difficulty deploying the left atrial disc, which appeared unable to form properly due to interference with surrounding anatomical structures.As a result, the physician formed the left disc deeper in the left atrium and the device was implanted with good result.Following the procedure, the patient experienced chest pain.The day after the procedure a pericardial effusion was noted and therapeutic pericardiocentesis was performed.

Manufacturer Narrative

Describe event or problem - this section has been corrected to reflect the correct size of device selected for the procedure.The initial medwatch report event description said the physician selected a 30mm gore cardioform septal occluder; however, the physician actually selected a 25mm gore cardioform septal occluder.Only the device size noted in the event description was incorrect.The device information throughout the initial report is correct.

Event Description

It was reported the physician selected a 25mm gore cardioform septal occluder to close a patent foramen ovale.The physician experienced difficulty deploying the left atrial disc, which appeared unable to form properly due to interference with surrounding anatomical structures.As a result, the physician formed the left disc deeper in the left atrium and the device was implanted with good result.Following the procedure, the patient experienced chest pain.The day after the procedure, a pericardial effusion was noted.

• Brand Name: GORE® CARDIOFORM SEPTAL OCCLUDER
• Type of Device: OCCLUDER, TRANSCATHETER SEPTAL
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: marci stewart ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5785117
• MDR Text Key: 49277928
• Report Number: 2017233-2016-00625
• Device Sequence Number: 1
• Product Code: MLV
• 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
• Report Date: 07/12/2016

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 Expiration Date: 04/18/2018
• Device Catalogue Number: GSX0025A
• Device Lot Number: 14983148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2016
• 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: 60 YR