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

Catalog Number PLC201000

Device Problems Improper or Incorrect Procedure or Method (2017); Human-Device Interface Problem (2949)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.(b)(4).The device was received for analysis.Further information will be provided.

Event Description

On (b)(6) 2018, the patient underwent endovascular procedure where the gore® excluder® aaa endoprosthesis was intended to be used for toracoabdominal treatment.It was reported that when the device was inserted in the 12fr flexor high-flex ansel guiding sheath, the physician felt some resistance right after the beginning of the introduction.The physician tried to remove the device, however, the endoprosthesis unintentionally released inside the sheath.The patient tolerated the procedure.According to the physician, incompatibility between sheath sizes (although they have the same inner diameter) may cause the problem.

Manufacturer Narrative

The device was sent for analysis and the device evaluation showed that the delivery catheter was broken at the trailing olive.The leading end had pulled out of trailing olive.The deployment knob was still attached to the catheter.The deployment line was extended out of the deployment line lumen of the catheter.The leading end of the device was still in the returned introducer sheath.The findings from the evaluation are consistent with the physician¿s observations.The gore® excluder® aaa endoprosthesis instructions for use (ifu) clearly states: do not attempt to withdraw any undeployed endoprosthesis through the introducer sheath.The sheath and catheter must be removed together.Do not continue to withdraw the delivery catheter if resistance is felt during removal through the introducer sheath.Forcibly withdrawing the delivery catheter through the introducer sheath when resistance is encountered has resulted in adverse events including catheter separation and reintervention.The cause for the catheter breakage could not be determined with the available information.The attempts to withdraw the undeployed device outside of the introducer sheath may have contributed to the event.Additionally, the gore® excluder® aaa endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (aaa) disease.In this case the gore® excluder® aaa endoprosthesis was intended to be used in the subclavian artery for thoracic aneurysm treatment.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: nataliya baramzina ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7516503
• MDR Text Key: 108498763
• Report Number: 2953161-2018-00047
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: PLC201000
• Device Lot Number: 14531537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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 Age: 66 YR
• Patient Weight: 62