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

Model Number	RLT281416
Medical Device Problem Codes	Material Protrusion/Extrusion (2979); Sharp Edges (4013)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that the lot of the gore® excluder® trunk-ipsilateral leg component rlt281416 / (b)(4) involved in this event met all pre-release specifications.The gore® excluder® trunk-ipsilateral leg component rlt281416 / (b)(4) has been returned to gore and an engineering evaluation is currently being performed.
Event or Problem Description
On (b)(6), 2021, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was treated with gore® excluder® aaa endoprostheses.Prior to the procedure, a gore® excluder® trunk-ipsilateral leg component rlt281416 was inspected and prepared and no abnormalities were observed.As unusual resistance was felt when attempting to advance the component through an 18 french gore® dry seal flex introducer sheath inside the patient, the physician retracted the rlt281416 device catheter out of the sheath.However, it was reported that during an immediate renewed advancement attempt, the component became stuck due to the resistance accompanied by a sudden considerable gush of blood out of the sheath.As it was surmised the sheath was damaged, it was retracted from the patient together with the rlt281416 component.Subsequently, the wound in the left groin was pressured against with a gauze and the rlt281416 catheter was inspected.It was found that the lock pin was protruding in a 90 degree angle just below the leading olive.The sheath was not particularly inspected but it was reportedly believed that the protruding lock pin had perforated the inflated valve, pointing to a possible reason for the blood spill.The physician replaced both devices with new ones and no further issues were reported.The procedure concluded as planned.
Additional Manufacturer Narrative
Gore® excluder® trunk-ipsilateral leg component rlt281416 / 22894027 was returned to gore and an engineering evaluation was performed.A visual inspection of the device showed that the lock pin was dislodged from the olive and bent 90 degrees from the device.A further close examination of the leading olive revealed a tear in the lock pin hole.Based on the findings from this evaluation, the physician¿s observation that ¿that the lock pin was protruding in a 90 degree angle just below the leading olive¿ was confirmed.The likely cause for the lock pin being dislodged from the leading olive and bent (kinked) could not be determined with the available information.The likely cause for the tear in the leading olive is the lock pin tearing through the side of the olive.
Additional Manufacturer Narrative
H6: medical device problem code: updated code.H6: investigation findings: updated/added codes (3211, 140).

• 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: 11787084
• Report Number: 3007284313-2021-01421
• Device Sequence Number: 19763503
• Product Code: MIH
• UDI-Device Identifier: 00733132622542
• UDI-Public: 00733132622542
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/19/2021

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: 12/01/2023
• Device Model Number: RLT281416
• Device Catalogue Number: RLT281416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 07/07/2021; 08/19/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 08/06/2021; 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Weight: 83