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

Model Number 26929

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2021

Event Type  malfunction  

Event Description

It was reported that stent foreshortening occurred.The target lesion was a 70% stenosed left superficial femoral artery (sfa) with a dissection in the mid portion, and another 60%-70% lesion in the proximal portion.A 6x120x130mm innova vascular stent was advanced to the mid sfa lesion and was positioned nicely.As the physician deployed the stent, the proximal end of the stent foreshortened 20mm-30mm, barely covering the lesion.Then a 6x100x130 innova vascular stent was advanced to the proximal sfa lesion.Again, as it was deployed, the proximal end of the stent foreshortened by 40mm.The physician was not satisfied with the foreshortening.The stents were post dilated with a mustang balloon catheter and under ivus they had good vessel wall apposition.The procedure was completed with no complications.

• 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: 12507850
• MDR Text Key: 272516380
• Report Number: 2134265-2021-11786
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08714729874034
• UDI-Public: 08714729874034
• 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: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26929
• Device Catalogue Number: 26929
• Device Lot Number: 0024727255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 63