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

Catalog Number GSX0030A

Device Problems Detachment Of Device Component (1104); Sticking (1597)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/01/2015

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 an atrial septal defect sized to 16.8mm with fluoroscopy.Following deployment, a slight residual shunt was seen.The physician opted to lock the device to further assess apposition.The device was locked and the shunt appeared to be even smaller than previously noted.As the retrieval cord was removed, imaging noted the device being pulled back into the delivery catheter, indicating the device had not actually locked.The physician rotated the catheter and the lock loop released; however, part of the right disc could be seen in the left atrium.The physician captured the device with a snare but was unable to fully retrieve it into the sheath as the right atrial eyelet was caught at the catheter tip.The retrieval sheath and device were pulled into the femoral vein together when the snare slipped off the device.The physician made several attempts with various techniques and tools to remove the device but was ultimately unsuccessful.After several hours, a vascular surgeon was brought in to attempt a cut down; however, at this time imaging showed internal bleeding from the femoral vein, and the patient was transferred to the operating room for emergency surgery.The device was removed and the vein was repaired.The patient was doing well following surgery and no transfusion was required.

Manufacturer Narrative

The occluder was returned to gore for an engineering analysis.As received, the occluder had several fractures of the frame and damaged leaflet material.The damage to the occluder is consistent with methods described in the event that were used to retrieve the device.Due to the condition of the returned occluder the cause of the reported event cannot be determined.The delivery system was not returned to gore for analysis, and therefore cannot be examined for the cause of the reported delayed lock release.Based on inspection of this device, there is no indication that the reported event was due to design or manufacture of the device.

• 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 86001
• Manufacturer Contact: marci stewart ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5166305
• MDR Text Key: 28882492
• Report Number: 2017233-2015-00719
• 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: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: GSX0030A
• Device Lot Number: 14226296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2015
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2015
• 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: 6 YR
• Patient Weight: 28