MAUDE Adverse Event Report: W. L. GORE ASSOCIATES, INC. GORE VIABAHN VBX BALLOON EXPANDABLE ENDO; ILIAC COVERED STENT, ARTERIAL

Model Number BXA082901A

Device Problems Retraction Problem (1536); Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problems Adhesion(s) (1695); Stenosis (2263)

Event Date 05/17/2021

Event Type  Injury  

Event Description

While placing stent, stent deployed in superior mesenteric artery and was irretrievable.Procedure converted from percutaneous to open laparotomy.From operative note: preoperative diagnosis: chronic mesenteric ischemia.Postop diagnosis: chronic mesenteric ischemia.Procedure(s): right common femoral artery ultrasound guided access; non-selective catheter placement, aorta; aortogram; selective catheter placement, celiac artery; celiac artery stent (7 x 22 mm icast) and post dilated proximal to 9 mm; exploratory laparotomy; lysis of adhesions x 15 minutes; removal of stent and balloon from superior mesenteric artery; superior mesenteric endarterectomy with bovine patch angioplasty.Complications: stent came free from delivery system in superior mesenteric artery.Ultimately this was removed through an open procedure blood loss: 200 cc.Procedure findings: stenosis of celiac and superior mesenteric arteries; celiac artery open after stent placement; stent became dislodged from delivery system in superior mesenteric artery and could not be captures.On open exploration there were significant adhesions requiring lysis for exposure; stent and balloon seen within superior mesenteric artery and removed; completion angiography shows widely patent mesenteric vessels.Indications: (b)(6) year old female with a history of chronic obstructive pulmonary disease, prior tobacco use, and symptoms of mesenteric ischemia.She had borderline velocities of her celiac artery.Her inferior mesenteric artery had velocities above 400 cm/s which are severely elevated though this is a smaller vessel and we discussed not treating it.Most significantly she had velocities above 300 cm/s in the proximal superior mesenteric artery which then diminished to 78 cm/s with dampened waveforms which is consistent with significant stenosis.We discussed the risks and benefits of angiography with stent placement to help relieve her symptoms and she consented to proceed.Procedure in detail: was brought to the operating room and laid supine.She was under monitored anesthesia care.She was prepped and draped sterile and a time out was performed.I accessed the right common femoral artery under ultrasound guidance with a 21 gauge needle after giving 1% lidocaine for local anesthesia.I used a micropuncture set and upsized to a 6 french sheath.An omniflush catheter was advanced into the aorta and an aortogram was obtained.The sheath was exchanged for a 45 centimeter 7 french conformable sheath which was advanced to the paravisceral aorta.We gave systemic heparin for anticoagulation and re-dosed at 45 minute intervals.With this sheath and a bern catheter, i accessed the celiac artery.A 7 x 22 mm icast stent was put into position at the origin and deployed.The proximal end was flared in the aorta with a 9 millimeter balloon.We then shot a completion angiogram showing a good result at this location.The sheath was withdrawn back into the aorta and positioned to access the superior mesenteric artery.This vessel had a steep downward angle.The conformable sheath was put into position and with a bern catheter i was able to access the artery.An 8 x 39 mm vbx stent was selected to land short of the first branch distal and have the proximal stent extend just into the aorta and flare.Unfortunately, the stenotic area and the steep angle of the artery made positioning difficult.The stent preferentially would move distal into the artery in a position where the first branch would occlude.On pulling it back it the forces would pull the sheath too far into the proximal artery not giving the stent space to deploy.I decided to remove the stent and exchange for a shorter one to allow better maneuverability.In pulling the stent back into the sheath it slid off of the delivery system and remained suspended in the proximal superior mesenteric artery.As the wire was still in place i advanced an 8 millimeter balloon.This was able to get into the stent.The stent was too far distal where deployment would have caused occlusion of side branches to i only partially inflated the balloon to capture the stent and withdraw it to the origin of the vessel.The balloon got forced out proximal to the stent and i could not readvance it.I advanced a quickcross catheter beyond the stent and exchanged for a v14 wire.I advanced a 2.5 millimeter balloon beyond the stent and inflated it with plans to pulls the stent back to the sheath and remove everything with the stent captured.The stent appeared to have been trapped in the stenosis and would not move.Without much force, the balloon pulled into the stent and then became dislodged from the catheter.When the catheter came back we lost wire access.I called my partner for help with further endovascular means to try to capture the stent.He scrubbed in to assist.We passed a second 0.014" wire as a safety wire into the sma beyond the stent and balloon.A 10 en-snare was advanced and we were able to snare the stent.The same combination of forces however did not allow the stent to be retracted and ultimately it became clear that we would no be able to pull this out from the origin of the artery.I also became concern that even if we were able to apply enough force to remove the stent in this direction that it would cause a significant arterial injury.See "what was original intended procedure" for continuation of event description.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDO
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE ASSOCIATES, INC.; 301 airport rd; elkton MD 21921
• MDR Report Key: 11965056
• MDR Text Key: 255123682
• Report Number: 11965056
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BXA082901A
• Device Catalogue Number: BXA082901A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/25/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 27375 DA
• Patient Weight: 72