MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number RMT281418

Device Problems Retraction Problem (1536); Sticking (1597); Material Deformation (2976); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.The patient had very tortuous iliac arteries.It was reported that a dsl 18fr sheath was being used, the main body rmt281418/12505165 was being positioned for deployment, there were several attempts made to reposition the device.The physician felt the device had coiled and wanted to remove tension from the delivery device.Upon attempting to retract the delivery device, the distal end of the endograft became flowered and got caught on the tip of the sheath.The physician chose to bareback and deploy the rmt device in the desired location.The physician removed the dsl sheath and chose to use a new one to complete the procedure and there was no further sequela.The patient tolerated the procedure.

Manufacturer Narrative

Patient medications: gabapentin, ibuprofen the review of the manufacturing paperwork verified that this lot met all pre-release specifications.

Manufacturer Narrative

The device was returned to gore for evaluation.Per gore engineering the sheath was visually inspected and found to have a split in the body of the sheath and towards the hub, was in two pieces, and damage to the tip.The root cause of the damage to the tip of the dryseal device is consistent with attempting to withdraw a flared endograft device as described in the event description.The root cause of the dryseal device being in two pieces and split throughout the device could not be determined with the currently available information.The warnings and precautions section of the ifu states: ¿warning: do not continue to withdraw the delivery catheter if resistance is felt during removal through the introducer sheath.Forcibly withdrawing the delivery catheter through the introducer sheath when resistance is encountered has resulted in adverse events including catheter separation and reintervention.¿ ¿warning: do not attempt to withdraw any undeployed endoprosthesis through the 12 fr, 18 fr or 20 fr introducer sheath.The sheath and catheter must be removed together.¿.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86001
• Manufacturer Contact: rachael chascsa ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4207802
• MDR Text Key: 5147629
• Report Number: 2017233-2014-00558
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020004
• 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: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: RMT281418
• Device Lot Number: 12505165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2014
• 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 Age: 64 YR
• Patient Weight: 84