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

Model Number	26924
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent was shorter than the labeled size.Two 7x80x130 innova self expanding stents were selected for use for a stenting procedure in the right iliac artery.The first stent was deployed successfully and had a length of 80mm.The second stent was also deployed successfully.Balloon angioplasty was done after both stents were deployed.Upon radiographic imaging, it appeared that the second stent was significantly shorter, around 60mm fully deployed.The stent still covered the entire lesion.The case was completed with the same devices.There were no patient complications reported.Device evaluated by mfr: the outer shaft, middle shaft, inner sheath and the remainder of the device were checked for damage.The outer sheath was kinked at the nosecone.The inner liner showed a kink at 9.5cm from the tip.The stent was not returned; therefore, the length of the stent could not be measured.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• 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: 7852154
• Report Number: 2134265-2018-60506
• Device Sequence Number: 1678602
• Product Code: NIP
• UDI-Device Identifier: 08714729874102
• UDI-Public: 08714729874102
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/06/2018

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: 11/08/2020
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0021356439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR