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

Catalog Number RLT261414

Device Problems Complete Blockage (1094); Collapse (1099); Insufficient Information (3190)

Patient Problems Occlusion (1984); Thromboembolism (2654); Vascular Dissection (3160)

Event Date 05/20/2019

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the devices could not be conducted as the lot/serial numbers are not available.Further information was requested but was not available.(b)(4).The explanted devices will be sent for analysis.Further information will be provided.

Event Description

On (b)(6) 2017, this patient underwent an endovascular abdominal aneurysm repair and was treated with gore® excluder® aaa endoprostheses.On (b)(6) 2019, follow-up imaging reportedly revealed the gore® excluder® aaa endoprosthesis featuring c3® delivery system (rlt 261414/unknown) was compressed and all devices and iliac arteries were totally thrombosed.On (b)(6) 2019, the endoprostheses were explanted and subsequently replaced with a dacron® stent graft.The patient tolerated the procedure.According to the physician the acute dissection caused the problem.Further information was requested but was not available.

Manufacturer Narrative

H6: conclusion codes.

Manufacturer Narrative

Additional information: b5: event description.D10: device available for evaluation.H3: device evaluated by manufacturer.Code 3221: a review of the manufacturing records for the devices could not be conducted as the lot/serial numbers are not available.Further information was requested but was not available.The explanted devices were sent to gore for analysis and the following was found: submitted in formalin were two tissue fragments of unknown origin (tissue 1-2) and three gore® excluder® aaa endoprostheses in three segments; one trunk ¿ ipsilateral leg endoprosthesis fragment (tf-1) containing a contralateral leg endoprosthesis fragment (clf-1) within the transected ipsilateral leg, one trunk ¿ ipsilateral leg endoprosthesis fragment (tf-2) with one contralateral leg endoprosthesis fragment (clf-2) within and protruding out distally and one contralateral leg endoprosthesis (cl).Device fragments had been transected prior to arrival at w.L.Gore and associates.The lumens of all device and device fragments were patent.The abluminal surfaces were generally devoid of tissue, except scattered plaques of friable red/brown material.Tf-1 had a focal, relatively thin slab of hard, light tan tissue firmly adhered to the ablumen on the proximal end of the device; tissue was on the opposing surface of the flattened trunk.In the proximal lumen of tf-1, light tan tissue was observable, but could not be fully visualized, due to the device being flattened.Friable, light tan tissue was observed in the lumen of clf-1.The trunk region of tf-1, proximal to the area of bifurcation, retained a flattened/concave shape with wire discontinuities on the perimeter of the flattened area.Just distal of the area of bifurcation of tf-1, the ipsilateral leg was flattened/folded with surrounding wire discontinuities on opposing sides of the fold.A focal, circumferentially constraining thin slab of hard, light tan, firmly adherent tissue presenting in a curved fashion, was present on the distal ablumen of the cl; multiple wire discontinuities were noted in this region.Seven tissue specimens from the abluminal/luminal surfaces of the device, device fragments, and a free floating tissue specimen, were collected and histopathological examination was performed.Tissue situated on the abluminal surface of the devices, where present, was consistent with aneurysmal remnants.Regions immediately adjacent to device abluminal surfaces consisted of acute thrombus.Tissue situated on the luminal surface of the devices was consistent with acute or sometimes organizing, thrombus.Lymphohistiocytic inflammation also lined the luminal/abluminal device surfaces and was a consistent healing response to these endoprostheses at this implant time period.There was no gross or microscopic evidence of infection.The device and device fragments were subjected to an enzymatic digestion process to remove biologic debris.Following digestion all device and device fragments were examined for material disruptions with the aid of a stereomicroscope.The proximal trunk (tf-1) presented in a typical open and cylindrical fashion.Eleven wire discontinuities were present in the main body of the trunk, where the device had previously been flattened.Two holes were also present in the main body, which were consistent with a wire discontinuity puncturing the graft material.Five additional wire discontinuities were present, on the ipsilateral leg segment, on opposing sides where the device was flattened/folded prior to digestion.The cl had four wire discontinuities identified on opposing sides (two on each side) of cl.Three of the wire discontinuities were bordering the proximal end of the circumferentially constraining tissue, which was present prior to digestion.Representative wire discontinuity specimens were collected for metallurgical analysis from tf-1 and the cl.The examined wire discontinuities exhibited characteristics consistent with fracture, due to cyclic fatigue loading.No evidence of corrosion or abnormal abrasion was observed on the nitinol wire.The cause of the device compression is unknown.According to the physician, it was suspected as a hypothesis that may be the acute dissection caused the problem.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to occlusion of device or native vessel and surgical conversion.Additionally, according to the ifu, key anatomic elements that may affect successful exclusion of the aneurysm include significant thrombus and / or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.

Event Description

According to the physician, it was suspected as a hypothesis that may be the acute dissection caused the problem.

• 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: 8719331
• MDR Text Key: 148743082
• Report Number: 2017233-2019-00450
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2019

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 Catalogue Number: RLT261414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/20/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/23/2019; 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Weight: 70