MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AXILLOBIFEMORAL GORE-TEX® STRETCH VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Model Number SAX01D

Device Problem Torn Material (3024)

Patient Problems Death (1802); Exsanguination (1841)

Event Type  Death  

Manufacturer Narrative

Additional manufacturer's narrative: review of the manufacturing records could not be performed as no lot number information was provided.The device was not returned.Consequently, a direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no conclusion can be drawn.It is identified in the instructions for use: v.Technical information - b.Axillofemoral, femorofemoral, and axillobifemoral bypass procedures the success of axillofemoral, femorofemoral, and axillobifemoral bypasses depends in large part on the implantation technique.Specific complications associated with improperly implanted gore-tex vascular grafts in these positions may include suture hole elongation and mechanical disruption or tearing of the graft, suture line, or host vessel.Failure to follow these techniques may result in extreme blood loss, loss of limb function, loss of limb, or death.Although experience indicates that the incidence of these complications is extremely low, the following techniques must be employed if your treatment plan includes one of the above procedures: consider the patient¿s body weight and posture when determining the lengths of the tissue tunnel and the graft.¿ drape the patient to allow full movement of the arm, shoulder girdle or legs when determining correct graft length.¿ avoid protracted hyperabduction of the arm.Prolonged hyperabduction may lead to brachial plexus injury.¿ allow sufficient length to avoid stressing the axillary or femoral anastomoses throughout the full range of movement of the arm, shoulder girdle, or legs.Surgeons suggest that the graft be placed under both the pectoralis major and pectoralis minor.¿ cutting the non-stretch graft slightly longer than necessary has been reported by some surgeons to reduce further the risk of stressing the graft or the anastomoses.¿ for the fep ringed axillobifemoral gore-tex stretch vascular graft, refer to operative techniques - fep ringed axillobifemoral gore-tex vascular graft with removable rings and fep ringed stretch axillobifemoral gore-tex vascular graft with removable rings, ¿ for the fep ringed axillobifemoral gore-tex stretch vascular graft, moderately tension each component of the graft separately to avoid inadvertently placing excess tension on the graft suture line at the manufactured anastomotic site.It is also identified in the instructions for use: for all techniques: caution the patient against extreme or abrupt movements of the arm, shoulder, or legs during a convalescent period of six to eight weeks to allow for adequate healing.Routine activities such as reaching out in front, raising arms above the shoulder level, throwing, pulling, striding, or twisting should be avoided.Failure to follow these procedures may result in extreme blood loss, loss of limb function, loss of limb, or death.All information has been placed on file for use in tracking and trending.A response letter was not requested.

Event Description

Gore received a call from the hospital providing the following information: on an unknown date the patient underwent an ax-bi-fem procedure receiving an unknown gore vascular graft.On an unknown date the patient was doing weight lifting exercises and the proximal anastomosis tore.The patient was rushed to the hospital on an unknown date and expired due to blood loss on that date.

Manufacturer Narrative

As originally reported, the patient death was believed to be a result of the axillobifemoral gore-tex® stretch vascular graft.However, new information provided by the hospital on (b)(6) 2017 confirmed that the axillobifemoral gore-tex® stretch vascular graft did not cause or contribute to the patient death.Rather, the patient's death was due to the patient¿s condition (past history of deep vein thrombosis, peripheral vascular disease, type 2 diabetes, hypertension) and complications post-surgery, unrelated to the gore implant.However, the reported suture pull-out is believed to be device related.The medwatch report will be changed from a death report to serious injury report.Review of the manufacturing records verified that the lot met release requirements.

Event Description

Additional event information: on (b)(6) 2016 graft implanted; on (b)(6) 2016 the graft disrupts; repair procedure leads to ligation, which leads to thrombosis; on (b)(6) 2016 the patient's left leg is amputated; the patient expires 3 to 4 days later.

Manufacturer Narrative

Corrected data: event description, death: based on the sparse information obtained from the hospital and the hospital voluntary medwatch (mw5069716).Additional manufacturer narrative: the device was not returned to gore for examination.The device was grossly examined by gore at vanderbilt university hospital in the pathology department per institutional policy.Based on the examination performed, the observed suture pull-through and circumferential tear on the proximal end of the graft appeared consistent with a disruption of the proximal anastomosis related to tension on the device.It could not be confirmed whether the radial film had been disrupted during the initial implant procedure or if it was an effect of the rupture at the anastomosis.The observed material disruptions are not associated with the manufacturing process at w.L.Gore & associates.Proximal anastomosis disruption is a known complication associated with axillobifemoral bypass.The product instructions for use, sections v: b, vi, and vii: a, g provide implantation technical information and precautions on minimizing known causative factors of proximal anastomosis disruption of axillobifemoral bypass.Below are listed examples of the information: ¿ section v.Technical information b.: for all techniques: caution the patient against extreme or abrupt movements of the arm, shoulder, or legs during a convalescent period of six to eight weeks to allow for adequate healing.Routine activities such as reaching out in front, raising arms above the shoulder level, throwing, pulling, striding, or twisting should be avoided.Failure to follow these procedures may result in extreme blood loss, loss of limb function, loss of limb, or death.¿ section v.Technical information b.: the success of axillofemoral, femorofemoral, and axillobifemoral bypasses depends in large part on the implantation technique.Specific complication associated with improperly implanted axillobifemoral gore-tex® stretch vascular graft in these positions may include suture hole elongation, and mechanical disruption or tearing of the graft, suture line, or host vessel.¿ section v.Technical information b.Allow sufficient length to avoid stressing the axillary or femoral anastomoses throughout the full range of movement of the arm, shoulder girdle, or legs.¿ section v.Technical information b.Begin implantation by pulling the graft from the axillary counterincision to the first portion of the axillary artery.The graft must be placed under both the pectoralis major and the pectoralis minor muscles.The anastomosis must be performed in the first portion of the axillary artery, proximal to the thoracoacromial trunk.This entails dissection and proximal control at the axillary subclavian junction under the clavicle.Correct placement in this area prevents excessive movement of the artery/ graft junction.Do not place the anastomosis on the second or third portion of the axillary artery.Rotate the axillary artery with clamps so that the arteriotomy is made on its inferior border, placing the arteriotomy as close as possible to the first rib to minimize subsequent movement.Correctly bevel the axillary anastomosis.Stress on the anastomosis is minimized when the graft is placed parallel to the axillary artery.¿ section vii.Operative techniques g.1.: the fep ringed axillobifemoral gore-tex® vascular graft with removable rings and fep ringed axillobifemoral gore-tex® stretch vascular graft with removable rings are not elastic.The grafts should never be too short.¿ section vii.Operative techniques g.3.: failure to correctly cut the fep ringed axillobifemoral gore-tex® vascular graft with removable rings and fep ringed axillobifemoral gore-tex® stretch vascular graft with removable rings may damage the outer reinforcing layer and may result in aneurysmal dilatation or reduced suture retention strength.When cutting the graft, gently pull the graft taut and determine the correct length.Cut the graft with a sharp surgical instrument.Do not pull or peel the outer reinforcing layer from any area of the graft.If the outer reinforcing layer becomes frayed at the end of the graft, carefully trim that portion of the graft with a sharp surgical instrument.

Event Description

The following was reported to gore: the patient underwent an axillobifemoral bypass using a gore-tex® stretch vascular graft.On post-op day 40, it was reported that the patient was doing weight lifting exercise and the proximal anastomosis disrupted.It was reported he was rushed to the hospital where an ax-fem exploration revealed graft disruption.As a result, it was reported that graft ligation and massive transfusion were performed that day and above knee amputation was performed on the following day.It was reported the patient recovered well from those operations, however, the patient presented with fever several days later and subsequently ¿was determined that he likely had no residual pelvic blood flow given his thrombosed and now ligated graft, and that he would likely not survive given his pelvic ischemia, pressure ulcers and fevers¿.It was reported the patient subsequently expired.

• Brand Name: AXILLOBIFEMORAL GORE-TEX® STRETCH VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: craig bearchell ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6243966
• MDR Text Key: 64557285
• Report Number: 2017233-2017-00017
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K802095
• 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,Followup
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2020
• Device Model Number: SAX01D
• Device Catalogue Number: SAX01D
• Device Lot Number: 13994458
• 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: 07/01/2015
• 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 Outcome(s): Death
• Patient Age: 52 YR