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

Catalog Number PLC271400J

Device Problem Material Separation (1562)

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

Event Date 09/02/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021, the patient underwent an endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.After a trunk-ipsilateral leg endoprosthesis was deployed, a contralateral leg endoprosthesis (plc121000j) was implanted as extension of the ipsilateral leg (left limb).A contralateral leg endoprosthesis (plc141000j) was implanted in the contralateral leg (the right limb).Then, when another contralateral leg endoprosthesis (plc271400j) was implanted distally to extend the plc141000j, the physician mistook the bell bottom marker for the distal marker, and the plc271400j was deployed partially inside the sheath.The physician decided to push the stent graft of plc171400j using the dilator of the sheath.Prior to this, the delivery catheter of the plc271400j was removed, but there was resistance at the proximal end of the sheath.The physician pulled the catheter with strong force, and the leading end of the catheter separated from the delivery catheter.The separated leading end of the catheter was captured by a snare catheter and it was retrieved from the patient.The patient tolerated the procedure.

• Brand Name: GORE EXCLUDER AAA 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
• MDR Report Key: 12550471
• MDR Text Key: 281903136
• Report Number: 3013164176-2021-01244
• 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: company representative
• Type of Report: Initial
• Report Date: 09/29/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2024
• Device Catalogue Number: PLC271400J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR