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

Catalog Number PXL161407

Device Problem Sticking (1597)

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

Event Date 09/10/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, a patient was treated for an abdominal aortic aneurysm with gore® excluder® aaa endoprostheses.The trunk-ipsilateral leg endoprosthesis was advanced and deployed using the gore® c3® delivery system.An iliac extender endoprosthesis was attempted to be advanced to the ipsilateral side, however, it felt as if it were stuck in the external iliac artery.An attempt was made to remove the device.During attempted removal the stent expanded and separated from the delivery catheter.The olive was recaptured with a snare.A second device was introduced and deployed from the contralateral side without incident.The patient did well following the procedure.

Manufacturer Narrative

Results: a review of the manufacturing records for the device verified the lot met all pre-release specifications.Conclusion: the device was discarded therefore an engineering investigation could not be conducted.

Manufacturer Narrative

The engineering evaluation has been updated as follows: the device evaluation showed the following: the delivery catheter was returned for evaluation.Blood residue was observed on the throughout the delivery catheter.The leading end of the delivery catheter was separated at the trailing olive.The separated leading end of the catheter (endoprosthesis with the polyimide guidewire lumen) was not returned and could not be evaluated.No damage was seen on the trailing olive or the catheter shaft.The deployment knob was still screwed in the deliver catheter.The guidewire and introducer sheath were not returned and could not be evaluated.The excluder instructions for use (ifu) clearly states: do not attempt to withdraw any undeployed endoprosthesis through the 12 fr or 18fr introducer sheath.The sheath and catheter must be removed together.Do not continue advancing 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.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.After completion of the final assembly process in gore sunnyvale, the integrity of the product was inspected per md33988 aaa final inspection.A review of the master process sheet (mps) verified that the lot met the specification and acceptance criteria.The root cause for the reported difficulty to advance the device could not be determined with the currently available information.The root cause for the reported premature deployment could not be determined with the currently available information.The root cause for the broken leading end of the delivery catheter could not be determined with the currently available information.The results of this investigation did not warrant a capa.This type of occurrence will continue to be trended and appropriate actions will be taken as they are deemed necessary.

Manufacturer Narrative

Correction: part of the device system was returned and evaluated.The engineering evaluation stated the leading end of the delivery catheter was pulled out at the trailing olive.The pulled out leading end of the catheter (endoprosthesis with the polyimide guidewire lumen) was not returned and could not be evaluated.No damage was seen on the trailing olive or the catheter shaft.The deployment knob was still screwed in the delivery catheter.The guidewire and introducer sheath were not returned and could not be evaluated.The gore® excluder® aaa endoprosthesis instructions for use (ifu) clearly states: do not attempt to withdraw any undeployed endoprosthesis through the 12 fr or 18fr introducer sheath.The sheath and catheter must be removed together.Do not continue advancing 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.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.

• 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 SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: heidi inskeep ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4291301
• MDR Text Key: 5052650
• Report Number: 2953161-2014-00148
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2015

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: 04/30/2017
• Device Catalogue Number: PXL161407
• Device Lot Number: 12595945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/02/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/04/2015; 03/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2014
• 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
• Treatment: MEDICATIONS: ANTICOAGULANT MEDICATION (UNKNOWN)
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 60