MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE INNOVA¿; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	H74939293071230
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: returned product consisted of an innova self-expanding stent delivery system.The outer shaft, middle shaft, inner sheath and the remainder of the device were checked for damage.There was a kink at the nosecone of the device.There were also multiple kinks on the outer sheath.The proximal inner and the inner liner were separated from the handle.There were multiple kinks on the shafts when returned.There was no wire stuck in the device when returned.The handle was opened to investigate for additional damage.Visual analysis revealed that the mid-shaft inside of the handle was detached from the retainer clip which is an indication of high tensile force on the mid-shaft during the procedure.The stent was reportedly placed in the patient.Inspection of the remainder of the device, revealed no other damage or irregularities.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
It was reported that catheter entrapment on the guidewire occurred.The target lesion was located in the superficial femoral artery.After a guide wire crossed the lesion, a 7x120x130mm innova¿ stent was successfully implanted in the lesion.However, upon removal of the catheter off the guide wire, it became stuck with the wire.During removal, the innova shaft separated and was removed over the wire.The procedure was completed with angioplasty.No patient complications were reported and the patient's status was fine.

• Brand Name: INNOVA¿
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 7235912
• Report Number: 2134265-2018-00466
• Device Sequence Number: 832979
• Product Code: NIP
• UDI-Device Identifier: 08714729874126
• UDI-Public: 08714729874126
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 01/11/2018

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: 06/12/2020
• Device Model Number: H74939293071230
• Device Catalogue Number: 39293-07123
• Device Lot Number: 0020758576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR