MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number PAH091502

Device Problems Break (1069); Stretched (1601)

Patient Problem Vascular Dissection (3160)

Event Date 04/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products:.035" guide wire, gore viabahn endoprosthesis (pah091002 lot # 13365936).A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The imaging evaluation stated that there appears to be a true and false lumen at the level of the distal dta as well as multiple previous devices.Access appears to have been gained to what appears to be the false lumen.The catheter appears to be parked at about the origin of the celiac and the vessel does not appear to be selected.Wire access appears to have been gained to the celiac.Wire access appears to be maintained within the celiac.Wire access is no longer visible within the celiac and the undeployed device appears to be advanced to the level of the celiac.Device appears to be deployed.With available images, cannot confirm device was deployed within the celiac.Wire access to the celiac appears to have been once again gained.A second device appears to have been advanced and partially deployed.Post deployment angio appears to show late filling of the celiac.Dyna ct reconstructions ¿ celiac appear to originate off of what appears to be the false lumen.There does not appear to be any portion of the device(s) deployed within the celiac.Distal end of device(s) appears to be deployed within the abdominal aorta.Final angio again appears to show late filling of the celiac with no portion of the devices within the celiac.The endoprosthesis remained implanted, but the catheter was returned to gore for evaluation.An engineering evaluation is currently in process.

Event Description

On (b)(6) 2016, a 9 mm x 10 cm gore viabahn endoprosthesis (pah091002 lot # 13365936) was being placed into a celiac artery from the left femoral artery over a.035" guide wire.A previous cook evar procedure had been performed on this patient on an unknown date.It was stated that the patient had a dissection which resulted in a false lumen in the aorta.The gore viabahn endoprosthesis was advanced over the guide wire into the celiac artery and deployed successfully.It was stated that it was unknown if it was in the false or true lumen.It was reported to gore that the viabahn flipped out of the celiac artery and into the aorta.A decision was made to insert another viabahn (pah091502 lot #14074463) into the previous stent graft which was now in the aorta, to try and place it back into the celiac artery.The viabahn unintentionally deployed with the proximal end still inside the introducer sheath.The tip of the introducer sheath also appeared to be flared out and appeared damaged under fluoroscopy.The delivery catheter was difficult to remove from the introducer sheath so it was stated that considerable force was used to pull it out.The catheter stretched and broke and then the guide wire broke off.The guidewire portion that was protruding out of the sheath was clamped, and an additional surgeon was called for consultation.The viabahn remained implanted and the broken parts of the delivery catheter were removed.There was still a single filament of the deployment line which would not release from the endoprosthesis.The single filament of the deployment line was cut off below the skin level in the groin and left inside the patient.Surgical intervention was not needed and the patient was sent back to his room.

Manufacturer Narrative

The engineering evaluation stated that the following observations were made: the delivery system of the 9mm x 15cm device was returned to histology in 2 segments, without the deployment knob/line or endoprosthesis.A guidewire, syringe, hemostats, and introducer sheath were also returned.The distal tip was protruding approximately 8mm through an introducer sheath.The sheath and guidewire are not gore products, and were not evaluated.The reported break in the guidewire was noted.Approximately 65cm of the distal/tip end of the catheter tubing attached to the hub was stretched and necked down on the guidewire.Engineering evaluation conclusions are: the proximal dual lumen catheter shaft was broken.The catheter fragments or device components remain in the patient.The device migrated after deployment.The catheter/device was stuck on the guidewire.The device became stuck in the shaft of the introducer sheath during advancement.Based on the device examination performed, no manufacturing anomalies were identified.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: sandra whicker ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5642783
• MDR Text Key: 46169506
• Report Number: 2017233-2016-00462
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2018
• Device Catalogue Number: PAH091502
• Device Lot Number: 14074463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2016
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2015
• 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: 70 YR
• Patient Weight: 98