MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN ENDOPROSTHESIS - 3; NIP

Catalog Number PAHR062502E

Device Problems Break (1069); Activation Failure (3270)

Patient Problem No Code Available (3191)

Event Date 03/12/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the manufacturing records indicated the lot met pre-release specifications.The entire device was returned for investigation including a sheath.The sheath was not evaluated as it is not a gore product.The deployment line appeared to be broken.The section still attached to the deployment knob measured 182 cm, including three single fibers measuring approximately 12 cm, 6.5 cm and 0.3 cm.Approximately 3.2 cm of deployment line was still attached to the endoprosthesis.Approximately 5.5 cm of the endoprosthesis was expanded.The remainder of the endoprosthesis was constrained by the inner braided constraining line.Deployment was able to be continued with traction on the deployment line at the endoprosthesis.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

Event Description

It was reported that the patient underwent endovascular recanalization of the superficial femoral artery under general anesthesia.It was planned to treat the lesion with a gore® viabahn® endoprosthesis with propaten bioactive surface.After the physician pre-dilated the lesion to 5fr, they easily placed the viabahn® endoprosthesis in the intended position through a 7fr introducer sheath over a 260 cm long stiff guide wire.It was reported that the physician did not feel any resistance when advancing the viabahn® endoprosthesis.After the viabahn® endoprosthesis was correctly positioned the physician turned the deployment knob to initiate deployment of the viabahn® endoprosthesis, pulled the white deployment line and observed the deployment of the viabahn® endoprosthesis by fluoroscopic imaging.After the deployment line was completely extracted from the patient, the physician noticed that the viabahn® endoprosthesis had not fully deployed.Part of the viabahn® endoprosthesis remained constrained.To release the viabahn® endoprosthesis from the delivery catheter, the physician moved the delivery catheter and tried to withdraw it, but the viabahn® endoprosthesis did not release from the delivery catheter.It was reported that the physician then tried to retract the partially deployed viabahn® endoprosthesis back into the introducer sheath.But this did not work.Therefore the physician decided to convert to open surgery to remove the viabahn® endoprosthesis from the patient.To complete the procedure, the physician then used a bare metal stent (bard) to treat the lesion.It was mentioned that the procedure took two hours longer than planned.It was stated that the patient tolerated the procedure.

Manufacturer Narrative

Code 4112: dicom imaging series were requested but not provided to gore.Instead intraoperative angiographic jpeg images and one video of a pre-treatment computed tomography were provided for evaluation.Code 213: the imaging evaluation states the following: imaging provided for review for this event are intraoperative angiographic jpeg images and one (1) video of a pretreatment ct.Pre ct video illustrates that the right sfa appears to be occluded.Intraoperative angiographic jpeg image illustrates occlusive disease of the right sfa.A distorted intraoperative angiographic jpeg image illustrates what appears to be a partially deployed stent graft.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9936962
• MDR Text Key: 195377585
• Report Number: 2017233-2020-00237
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2022
• Device Catalogue Number: PAHR062502E
• Device Lot Number: 21451523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR