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

Catalog Number GSX0025A

Device Problems Break (1069); Misconnection (1399)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/21/2016

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The engineering investigation stated that it was reported that as the physician removed the retrieval cord from device lot #15239767, the cord broke and a portion of it embolized to the pulmonary artery.The investigation revealed that there was deformation of the eyeball lumens of the control catheter but all other delivery system components were unremarkable.The occluder, retrieval cord, and retrieval cord lock were not returned to gore for analysis.The cause of the broken retrieval cord is unknown and cannot be determined from the evidence available.(b)(4).

Event Description

It was reported the physician was implanting a gore® cardioform septal occluder to close an atrial septal defect.The device was deployed, but at lock release the locking loop missed the right atrial eyelet.The device was removed and another gore® cardioform septal occluder was deployed with good apposition to the septum.The device was locked.As the physician removed the retrieval cord, the cord broke.A portion of the retrieval cord embolized to the pulmonary artery and remains in the patient.

• 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: ashley marostica ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6037424
• MDR Text Key: 57928482
• Report Number: 2017233-2016-00804
• 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
• Report Date: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2018
• Device Catalogue Number: GSX0025A
• Device Lot Number: 15239767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2016
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2016
• 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): Other
• Patient Age: 40 YR
• Patient Weight: 54