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

Catalog Number CEB231210

Device Problems Break (1069); Separation Failure (2547); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the patient was implanted with gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses to treat an aneurysm of the right common iliac artery.A gore® excluder® iliac branch component ceb231210 was placed at the intended location.When initiating deployment, the device reportedly started to open as expected when, at the level of the external iliac artery, resistance was felt and the deployment line broke.The physician then utilized a balloon to dilate the sleeve of the device which initially resulted in successful further device deployment.However, when reaching the distal end of the device, it was not possible to deploy the final device portion of approximately 1 cm and it was therefore not possible to remove the delivery system from the device.In an attempt to solve the situation, it was decided to surgically access the patient for manual device deployment and delivery system removal.This was successfully performed and the procedure concluded with the ceb231210 component remaining in the patient.The patient is doing well.

Manufacturer Narrative

Device remains implanted, the delivery system is in transit to manufacturer.Engineering evaluation is anticipated.A review of the manufacturing records indicated the lot met all pre-release specifications.

Event Description

On (b)(6), 2022, the patient was implanted with gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses to treat an aneurysm of the right common iliac artery.A gore® excluder® iliac branch component ceb231210 was placed at the intended location.When initiating deployment, the device reportedly started to open normally as expected with no resistance when, at the level of the external iliac artery, the deployment line snapped.No repositioning or rotation was done to the device and the physician then utilized a balloon to dilate the sleeve of the device which initially resulted in successful further device deployment.However, when reaching the distal end of the device, it was not possible to deploy the final device portion of approximately 1 cm and it was therefore not possible to remove the delivery system from the device.In an attempt to solve the situation, it was decided to surgically access the patient for manual device deployment and delivery system removal.The deployment line was discovered during the open surgery which could be pulled which resulted in the intended deployment of the device without resistance.The procedure concluded with the ceb231210 component remaining in the patient.The patient is doing well.

Manufacturer Narrative

Update b5 describe event or problem.Update d9 date device returned to manufacturer and h3 device evaluated by manufacturer.Updated h6: added type of investigation code 4116, 4112, and 4111.Updated investigation findings code to 3252 and 213.Code 3233 is no longer applicable.Updated investigation conclusions code to 4315 and 22.Code 11 is no longer applicable.The device remains implanted, (part of) the delivery system has been returned to manufacturer and the device evaluation showed the following: -only pieces of the delivery catheter were returned for evaluation.-the trailing hub portion of the catheter had been cut off and not returned for evaluation.-the first deployment knob with attached deployment line was not returned for evaluation.-the blue outer shaft of the catheter was cut open exposing the deployment line lumens.-the catheter had also been cut 7.5 inches from the leading end of the catheter.-the leading olive had separated from the catheter.-the broken second deployment line was returned for evaluation.The deployment line was in two pieces.The deployment line attached to the knob was 56 cm.The broken off end of the deployment line was 21 cm.-the broken ends of deployment line fiber were frayed.The fiber was sent for scanning electron microscopy (s.E.M) imaging.The broken ends of the deployment line appeared to have a tensile failure of the fiber.-image from field appeared to show a section of device remaining constrained by the deployment sleeve.Based on the findings from this evaluation, the physician¿s observation that the second deployment line broke during deployment was confirmed.The likely cause for the break in the second deployment line during deployment could not be determined from the currently available information.Code 3252 refer to the type of investigation code 10 (testing of the returned device), 4116 (incomplete device returned), and 4112 (analysis of data provided by user/third party (images from field)).Code 213 refers to the type of investigation code 3111 (analysis of production records).Conclusions code 4315: the likely cause for the break in the second deployment line during deployment could not be determined from the currently available information.A review of the manufacturing records indicated the lot met all pre-release specifications.According to the gore® excluder® iliac branch endoprostheses instructions for use (ifu), adverse events that may occur and / or require intervention include but are not limited to incomplete component deployment.Corrected h6: updated health effect - impact code to 4631 - more complex surgery.Code 4625 was inadvertently entered, but correct code should be 4631.

• Brand Name: GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14110088
• MDR Text Key: 290541626
• Report Number: 3013164176-2022-01351
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CEB231210
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2022
• Initial Date FDA Received: 04/14/2022
• Supplement Dates Manufacturer Received: 06/20/2022
• Supplement Dates FDA Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2021
• 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: 78 YR
• Patient Sex: Male