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

Model Number	26928
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2021
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12507807
• Report Number: 2134265-2021-11788
• Device Sequence Number: 3067603
• Product Code: NIP
• UDI-Device Identifier: 08714729874027
• UDI-Public: 08714729874027
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/06/2024
• Device Model Number: 26928
• Device Catalogue Number: 26928
• Device Lot Number: 0024733552
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/21/2021
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 63