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

Model Number 26924

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2018

Event Type  malfunction  

Event 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
• 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7852154
• MDR Text Key: 119493001
• Report Number: 2134265-2018-60506
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08714729874102
• UDI-Public: 08714729874102
• 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: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR