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

Model Number	PLC141200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medications include but are not limited to: heparin, flomax, insulin (humalog) at meals and bedtime.Patient medical history includes but is not limited to: htn, hyperlipidemia, l2,l3,l4 damage, kidney stones, dmii, positive (b)(6) swab (b)(6) 2020, multiple knee surgeries, bilateral hernia repair, aaa, rcia stent graft.
Event or Problem Description
On (b)(6) 2020, this patient underwent endovascular treatment for an isolated right common iliac artery (rcia) aneurysm and was implanted with gore® excluder® aaa endoprostheses and coiling of the right hypogastric artery.Two contralateral leg components were implanted in the rcia.The patient tolerated the procedure without any reported issues.On (b)(6) 2020, the patient presented to the hospital with acute right flank pain and right ureteral calculus and underwent treatment for kidney stones.During intraoperative imaging, a foreign body was visualized within the abdominal aorta and left common iliac artery.The foreign body was removed using a ensnare catheter and was identified to be the leading olive and approximately 17.5 cm of the delivery catheter inner lumen of a gore® contralateral leg component initially implanted.The patient tolerated the procedure.During the original implant there had been no issues with advancement or withdrawal of any of the devices.It was reported that during preparation of this device by the tech, much difficulty was encountered during removal of the device packaging mandrel.The tech had to pull very forcefully to get it out and may have compromised device integrity.Additionally, it was reported that no angiography of the abdominal aorta or the left side was performed as the patient was being treated for an isolated rciaa.
Additional Manufacturer Narrative
B3: corrected/added information.
Additional Manufacturer Narrative
The leading end of a delivery catheter, the leading olive attached to the gold braid guidewire lumen, were returned for evaluation and showed the following: there was no evidence of a tensile break of the guidewire lumen.The leading end of the catheter appeared to have pulled out of trailing olive bond.The leading olive was still bonded to the guidewire lumen.The packaging mandrel used was not returned and could not be evaluated.The findings from the evaluation are consistent with the physician¿s observations for leading end of the catheter broken.The reported difficulties removing the packaging mandrel could not be confirmed with the currently available information.The excluder instructions for use (ifu) clearly states: 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 breakage or separation resulting in potential patient harms.The cause for the catheter breakage could not be determined from the currently available information.The cause for the packaging mandrel being difficult to remove could not be determined with the currently available information.H6: code 213- a review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.
Additional Manufacturer Narrative
H6: code 213- a review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.

• Brand Name: GORE EXCLUDER AAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10502469
• Report Number: 3013164176-2020-01037
• Device Sequence Number: 3222751
• Product Code: MIH
• UDI-Device Identifier: 00733132618675
• UDI-Public: 00733132618675
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/17/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/21/2023
• Device Model Number: PLC141200
• Device Catalogue Number: PLC141200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Initial Date Received by Manufacturer: 08/30/2020
• Supplement Date Received by Manufacturer: 08/30/2020; 08/30/2020; 08/30/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 09/10/2020; 10/15/2020; 12/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 139