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

Catalog Number PAHR052502E

Device Problems Break (1069); Detachment Of Device Component (1104); Positioning Failure (1158); Physical Resistance (2578)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/08/2017

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The delivery catheter was sent for analysis.Further information will be provided.Pahr052502e/ 16130687 udi# (b)(4).

Event Description

On (b)(6) 2017, a gore® viabahn® endoprosthesis with heparin bioactive surface (5mm x 25cm) was intended to be used for treatment of a superficial femoral artery occlusion.A 7fr cordis bright tip sheath, a terumo 0.035 guidewire with a length of 260 cm and a bard pta balloon for pre-dilation were used during the procedure.The initial plan was to place a viabahn (pahr052502e/ 16130687) 2 cm above the knee joint followed with a 5 mm x 15 cm viabahn until the origin of the sfa.Reportedly, the first 20 cm of the viabahn deployed without any problem.It was impossible to deploy the last 5 cm.The physician decided to pull the deployment line harder which at first let to a `bowstring` effect of the viabahn catheter and eventually the line was broken.There was already a sheath placed retrograde in the popliteal artery to cross the lesion, this was not possible antegrade.The physician tried to perform a pta ballooning of the sub deployed viabahn retrograde to make it deploy completely but this was impossible.It was reported that the physician opened the left groin and tried to pull the viabahn catheter back through the sheath and it made the viabahn came loose from the catheter.The leading olive of the delivery catheter couldn't pass the undeployed part of the viabahn and with pulling harder the catheter, the sub deployed viabahn moved in the patient.The anatomical location of the viabahn was now 2 cm of the origin of the sfa, the device was pulled back approx 15 cm in the patient.The physician decided to do a cut down of the proximal sfa and was able to catch the rest of the deployment line.The physician deployed the last 5 cm of the device and decided to place a biologic patch over the viabahn to the common femoral artery to make sure there was a good inflow.The second device (pahr051502e /16145803) was placed to cover the whole lesion as planned.A control fluoroscopy was done with a good result.The patient tolerated the procedure.

Manufacturer Narrative

The engineering evaluation was completed.The engineering evaluation stated the following: the catheter assembly arrived in 2 pieces, appearing severed at the distal shaft, upon which the endoprosthesis was mounted.The distal tip and distal shaft up to the cut measured approximately 22 cm.There was a kink in the distal shaft, approximately 5 cm from the transition.The deployment line was separate from the catheter and was also cut into 2 portions.The longer portion, connected to the deployment knob, was tangled up in knots.The shorter portion measured approximately 23 cm, with one fiber extending an additional 13 cm.Based on the device examination performed, no manufacturing anomalies were identified.According to the gore® viabahn® endoprosthesis with propaten bioactive surface instructions for use, (ifu), inadvertent, partial, or failed deployment or migration of the endoprosthesis may require surgical intervention.

Event Description

On (b)(6) 2017, a gore® viabahn® endoprosthesis with heparin bioactive surface (5mm x 25cm) was intended to be used for treatment of a superficial femoral artery occlusion.A 7fr cordis bright tip sheath, a terumo 0.035 guidewire with a length of 260 cm and a bard pta balloon for pre-dilation were used during the procedure.The initial plan was to place a viabahn (pahr052502e/ 16130687) 2 cm above the knee joint followed with a 5 mm x 15 cm viabahn until the origin of the sfa.Reportedly, the first 20 cm of the viabahn deployed without any problem.It was impossible to deploy the last 5 cm.The physician decided to pull the deployment line harder which at first led to a `bowstring` effect of the viabahn catheter and eventually the line was broken.There was already a sheath placed retrograde in the popliteal artery to cross the lesion, this was not possible antegrade.The physician tried to perform a pta ballooning of the sub deployed viabahn retrograde to make it deploy completely but this was impossible.It was reported that the physician opened the left groin and tried to pull the viabahn catheter back through the sheath and it caused the viabahn to come loose from the catheter.The leading olive of the delivery catheter would not pass the undeployed part of the viabahn and with pulling harder the catheter, the sub deployed viabahn moved in the patient.The anatomical location of the viabahn was now 2 cm of the origin of the sfa, the device was pulled back approx 15 cm in the patient.The physician decided to do a cut down of the proximal sfa and was able to catch the rest of the deployment line.The physician deployed the last 5 cm of the device and decided to place a biologic patch over the viabahn to the common femoral artery to make sure there was a good inflow.

Event Description

On (b)(6) 2017, a gore® viabahn® endoprosthesis with heparin bioactive surface (5mm x 25cm) was intended to be used for treatment of a superficial femoral artery occlusion.A 7fr cordis bright tip sheath, a terumo 0.035 guidewire with a length of 260 cm and a bard pta balloon for pre-dilation were used during the procedure.The initial plan was to place a viabahn (pahr052502e/ 16130687) 2 cm above the knee joint followed with a 5 mm x 15 cm viabahn until the origin of the sfa.Reportedly, the first 20 cm of the viabahn deployed without any problem.It was impossible to deploy the last 5 cm.The physician decided to pull the deployment line harder which at first led to a `bowstring` effect of the viabahn catheter and eventually the line was broken.There was already a sheath placed retrograde in the popliteal artery to cross the lesion, this was not possible antegrade.The physician tried to perform a pta ballooning of the sub deployed viabahn retrograde to make it deploy completely but this was impossible.It was reported that the physician opened the left groin and tried to pull the viabahn catheter back through the sheath and it caused the viabahn to come loose from the catheter.The leading olive of the delivery catheter would not pass the undeployed part of the viabahn and with pulling harder the catheter, the sub deployed viabahn moved in the patient.The anatomical location of the viabahn was now 2 cm of the origin of the sfa, the device was pulled back approx 15 cm in the patient.The physician decided to do a cut down of the proximal sfa and was able to catch the rest of the deployment line.The physician deployed the last 5 cm of the device and decided to place a biologic patch over the viabahn to the common femoral artery to make sure there was a good inflow.The second device (pahr051502e /16145803) was placed to cover the whole lesion as planned.A control fluoroscopy was done with a good result.

• 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: nataliya baramzina ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6810283
• MDR Text Key: 83656520
• Report Number: 2017233-2017-00425
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2020
• Device Catalogue Number: PAHR052502E
• Device Lot Number: 16130687
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2017
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR