MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number RLT261412

Device Problems Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923); Unintended Movement (3026); Migration (4003)

Patient Problem Aneurysm (1708)

Event Date 05/26/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: patient medications include but are not limited to: acetaminophen 650 mg oral tablet, extended release, 1-2 tab(s), oral, q8hr (interval), prn, aspirin, 81 mg, oral, daily, gabapentin 300 mg oral capsule, 300 mg= 1 cap(s), oral, hs, 3 refills, ibuprofen 200 mg oral tablet, 400 mg= 2 tab(s), oral, q8hr (interval), lisinopril 5 mg oral tablet, 1 tab(s), oral, daily, 11 refills,magnesium citrate 1.745 g/30 ml oral liquid, 8.725 gm= 150 ml, oral, neurontin 100 mg oral capsule, 100 mg= 1 cap(s), oral, tid, 11 refills, pravastatin 20 mg oral tablet, 20 mg= 1 tab(s), oral, daily, 3 refills.According to the instructions for use (ifu) for the gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses; adverse events that may occur include, but are not limited to: endoprosthesis: component migration.A review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.

Event Description

On (b)(6) 2019, this patient underwent endovascular treatment for a common iliac artery aneurysm and was implanted with gore® excluder® aaa endoprostheses featuring c3® delivery system and gore® excluder® iliac branch endoprostheses.The patient tolerated the procedure.On (b)(6) 2019, it was reported that the patient the patient presented to the hospital and was experiencing back pain.Imaging was performed and showed distal migration and a collapsed/compressed body of the excluder® trunk ipsilateral component.The patient underwent reintervention and a ax-bifemoral procedure (r axillary to r femoral; r femoral to l femoral) was performed with 8mm ringed grafts.The patient tolerated the procedure.No devices were explanted.

Manufacturer Narrative

As gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: plc271000/17717147.

Manufacturer Narrative

Images were provided to gore and an evaluation was performed and showed the following: pre-operative images 01/25/2019: diameter just distal to the left renal artery as being about 21mm diameter 15mm distal to the left renal artery as being about 21mm the length from the left renal artery to the aortic bifurcation appears to be about 74mm.The lci diameters range from 11.6mm to 31.9mm.The lei diameters range from 10.0mm to 13.7mm.The diameters of the lii appear to range from 8.5mm ¿ 11.2mm.The length to the first major branch vessel appears to be 40mm.The minimal vessel diameter within the ibe proximal implantation zone appears to be 23.7mm.Post-operative images 05/10/2019: length from the left lowest renal to the proximal end of the device appears to measure ~ 3.2 mm length from the left lowest renal to the circumferential device appears to measure ~ 15.7 mm post-operative images 05/26/2019: comparison of the post-operative images show what appears to be compression of the proximal end of the trunk with occlusion throughout most of the devices on the 05/26/2019 time points.There appears to be flow re-constituting in the distal aspect of device on the left.Mid-distal lei appears to have less flow on the 05/26/2019 when compared to 05/10/2019.

Manufacturer Narrative

Concomitant medical products: plc271000.Udi: (b)(4).Additional/corrected information a review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.

Manufacturer Narrative

G9: please note that this event was reported in medwatch #3013164176-2019-00068.Details of the event required a separate medwatch submission for the iliac branch component; as such this medwatch is being submitted.H6: code 22: according to the instructions for use (ifu) for the gore® excluder® aaa endoprosthesis; adverse events that may occur include, but are not limited to: endoprosthesis: component migration, occlusion of device or native vessel.Additional images from the index procedure were obtained and evaluated by gore and show the following: as some of the images received were not dicom format, a full imaging evaluation could not be completed.Gore cannot make any conclusions or guarantees that non-dicom images are complete, accurate and lack alteration.Thus, findings noted are within the best ability of the reviewers but the extent of accuracy of the findings may be limited due to the completeness, format and/or quality of the images provided.Gore cannot guarantee that it has been able to capture all key findings or that the findings are accurate.Images received via (email) with no patient identifier or date of acquisition in image.On 04/10/2019: there appears to be a lack of wall apposition at the proximal end of the implanted device on the final procedural angiogram.On 05/10/2019: there appears to be a lack of wall apposition at the proximal end of the implanted device.On 05/26/2019: image shows what appears to be compression of the proximal end of the trunk with occlusion throughout the devices.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8688865
• MDR Text Key: 147652589
• Report Number: 3007284313-2019-00173
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132622443
• UDI-Public: 00733132622443
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/31/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2021
• Device Model Number: RLT261412
• Device Catalogue Number: RLT261412
• Device Lot Number: 17898506
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/19/2019; 06/19/2019; 06/24/2019; 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 77