MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA VASCULAR; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 26926

Device Problems Break (1069); Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/04/2021

Event Type  Injury  

Manufacturer Narrative

Device eval by manufacturer: returned product consisted of an innova self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the rack was separated.The distal section was inside the handle while the proximal section was missing.Microscopic examination revealed no additional damages.The handle was disassembled to find additional damages.The middle sheath was separated from the retainer.Inspection of the remainder of the device revealed no other damage or irregularities.

Event Description

It was reported that the stent became stuck on the guidewire, the stent partially deployed, and a small portion of the stent broke off in the artery.A 6mm x 150mm x 130cm innova vascular self-expanding stent and a 300cm v-18 control wire were selected for use in a procedure in the right superficial femoral artery (sfa).A contralateral approach was used to access the lesion.After pre-dilating with a 4mm balloon followed by a 5mm balloon, the innova device was inserted into the body over the existing v-18 control wire.Upon getting the stent into position in the right sfa, it was noted that the stent appeared to be getting stuck on guidewire and would not move freely.It was decided to proceed with stent deployment since the stent was in the correct location.The stent flowered open approximately 2% (approximately 2mm in diameter by 2mm in length) and then stopped.The system was jammed, and subsequently, the entire system (v-18 control wire and innova delivery system) was pulled back into the 6f non-boston scientific sheath, which was then removed from the left femoral artery.It was later discovered that a small portion of the stent that flowered open broke off inside the left femoral artery access site.Upon removal of the v-18 control wire, innova delivery system, and long sheath, a 6f short sheath was quickly inserted into the femoral artery and an angiogram was taken.The iliac vessels looked undamaged, but it was noted that the tip of the innova stent (ro markers plus perhaps 2mm of stent struts) remained in the femoral artery.It appeared that the portion of the stent, which was protruding out of distal end of the long sheath during removal, broke off just before removal from the body.The physician planned to have the patient immediately sent to the local hospital for a femoral endarterectomy where the fractured innova tip could be removed from the body.It was noted that the patient had a calcified stenosis just above the access site where the innova tip was inadvertently implanted.Approximately 10 minutes were spent earlier attempting to cross and get up and over the aortic bifurcation.Instead of stenting this segment, the physician had expressed verbally early on in the case that the patient needed a femoral endarterectomy in the near future to address this stenosis.Therefore, the broken stent removal was combined with a needed femoral endarterectomy.

• Brand Name: INNOVA VASCULAR
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11570729
• MDR Text Key: 242292217
• Report Number: 2134265-2021-03861
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08714729874041
• UDI-Public: 08714729874041
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26926
• Device Catalogue Number: 26926
• Device Lot Number: 0026126708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention