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

Catalog Number GSX0030A

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/22/2016

Event Type  malfunction  

Manufacturer Narrative

Results: a review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.The retrieval cord was returned for analysis.The retrieval cord lock was attached to the retrieval cord and the retrieval cord was tangled and knotted as received by (b)(4).The investigation revealed that there was extensive fraying of the retrieval cord approximately 128cm from the retrieval cord lock.The final length of the retrieval cord prior to device release could not be determined due to the state of the returned retrieval cord.The occluder and delivery system were not returned to gore for analysis.It is unknown where the piece of the retrieval cord left on the right atrial eyelet originated from, but the extensive fraying of the cord suggests that the piece may have originated from the frayed portion of the cord.It is unknown what caused the fraying of the retrieval cord.(b)(4).

Event Description

It was reported the physician selected a 30mm gore cardioform septal occluder to close an atrial septal defect balloon sized to 11-12mm.The device was deployed and locked without incident.While assessing the implant with intracardiac echocardiography, it was noted that there was a piece of retrieval cord attached to the right atrial eyelet.The physician opted to leave the fragment in place and concluded the procedure.

• 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: 6040684
• MDR Text Key: 57928350
• Report Number: 2017233-2016-00809
• 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: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2018
• Device Catalogue Number: GSX0030A
• Device Lot Number: 14983891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2016
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other
• Patient Age: 45 YR
• Patient Weight: 68