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

Model Number	26924
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent was bent.A 8 x 60 x 75 innova vascular stent was selected for use.During preparation, it was noted that the stent was bent and was unable to be used in the patient.The procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that the stent was bent.A 8 x 60 x 75 innova vascular stent was selected for use.During preparation, it was noted that the stent was bent and was unable to be used in the patient.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: 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 a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.Inspection of the remainder of the device, 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: 10464877
• Report Number: 2134265-2020-11681
• Device Sequence Number: 14125150
• Product Code: NIP
• UDI-Device Identifier: 08714729873822
• UDI-Public: 08714729873822
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2020

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: 06/03/2022
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0023894364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 09/24/2020
• Patient Sequence Number: 1
• Patient Age: 62 YR