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

Model Number	H74939293072030
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: returned product consisted of an innova self-expanding stent delivery system and no other devices.The outer shaft, middle shaft, inner shaft and the remainder of the device were checked for damage.The outer shaft showed buckling/damage at the nosecone.The remainder of the shaft showed multiple kinks.The middle shaft and the inner shaft were completely separated from the handle.There were also multiple kinks in the middle shaft and the inner shaft.The pull handle was deployed.The stent was not returned inside of the device.The guidewire was not returned with the device.With the shaft damage present the customer may have experienced an indication of a froze or sticky wire in the guidewire lumen.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
Event or Problem Description
It was reported that the catheter froze on the wire and the catheter shaft detached.The target lesion was located in the left superficial femoral artery.A 7 x 200 x 130 innova¿ stent was advanced and implanted.Upon removal of the stent delivery system, the physician had to give it a tug as it appeared to stick on the non-bsc guidewire near the sheath hub or in the sheath.The inner lumen of the innova broke off and remained on the wire.The physician used a forceps to grab the inner lumen and successfully removed it over the wire.Wire access was maintained and the same wire was used to finish the case.No patient complications were reported and the patient 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: 6264659
• Report Number: 2134265-2017-00022
• Device Sequence Number: 665255
• Product Code: NIP
• UDI-Device Identifier: 08714729874157
• UDI-Public: (01)08714729874157(17)20180930(10)18420569
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: H74939293072030
• Device Catalogue Number: 39293-07203
• Device Lot Number: 18420569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2016
• Initial Report FDA Received Date: 01/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO ADVANTAGE .035 GUIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention