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

Catalog Number HGB161007

Device Problems Break (1069); Sticking (1597); Physical Resistance (2578)

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

Event Date 07/12/2017

Event Type  malfunction  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.(b)(4).The device is going to be sent for analysis.Further information will be provided.

Event Description

On (b)(6) 2017, the patient underwent an endovascular procedure using gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses (ibe).Reportedly, the physician felt some resistance when attempting to advance an internal iliac component (hgb161007/16176887) through the gore® dryseal flex sheath (dsf1245/1v386846) and the device stuck inside the sheath.After several attempts to push the device, the physician noticed that the device was broken inside the introducer sheath.The physician decided to remove the sheath with the undeployed device and a tip, and use another internal iliac component.The procedure was conducted without any complications.The patient tolerated the procedure.

Manufacturer Narrative

On 08/02/2017, the device was sent to gore for analysis.Further information will be provided.

Manufacturer Narrative

Updated to indicate the date the engineering evaluation was completed.The device was received by gore on 8/17/2017.The device was sent to gore for analysis.The engineering analysis stated the following: the leading end of the device was broken inside the introducer sheath.The device had deployed inside of the introducer sheath because the deployment line had pulled out of the corset sleeve when the trailing end of the catheter was pulled away from the leading end.The delivery catheter had broken at the trailing olive.The catheter shaft of the delivery catheter was not returned for evaluation.The findings from the evaluation are consistent with the physician¿s observations.The root cause for the catheter breakage could not be determined with the available information.The excluder iliac branch endoprosthesis instructions for use (ifu) clearly states: do not advance the device outside of the sheath.The sheath will protect the device from catheter breakage or premature deployment while tracking it into position.Do not rotate any delivery catheters while the endoprosthesis is inside the introducer sheath.Catheter breakage or premature deployment may occur.Do not rotate the internal iliac component (iic) delivery catheter during delivery, positioning or deployment.Do not attempt to withdraw any undeployed endoprosthesis through the introducer sheaths.The sheath and undeployed device must be removed together.Do not continue advancing and withdrawing any portion of the delivery system if resistance is felt during advancement of the guidewire, sheath, or catheter.Stop and assess the cause of resistance.Vessel or catheter damage may occur.The excluder iliac branch endoprosthesis instructions for use (ifu) clearly states: do not advance the device outside of the sheath.The sheath will protect the device from catheter breakage or premature deployment while tracking it into position.Do not rotate any delivery catheters while the endoprosthesis is inside the introducer sheath.Catheter breakage or premature deployment may occur.Do not rotate the internal iliac component (iic) delivery catheter during delivery, positioning or deployment.Do not attempt to withdraw any undeployed endoprosthesis through the introducer sheaths.The sheath and undeployed device must be removed together.Do not continue advancing and withdrawing any portion of the delivery system if resistance is felt during advancement of the guidewire, sheath, or catheter.Stop and assess the cause of resistance.Vessel or catheter damage may occur.

• Brand Name: GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: nataliya baramzina ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6728599
• MDR Text Key: 80805116
• Report Number: 2953161-2017-00143
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2020
• Device Catalogue Number: HGB161007
• Device Lot Number: 16176887
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2017
• 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: 65 YR
• Patient Weight: 75