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

Model Number	H74939293061830
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: returned product consisted of an innova stent delivery system and no other devices.The outer shaft, middle shaft and the remainder of the device were checked for damage.The outer shaft was kinked at the nosecone.A kink was noticed on the outer sheath approximately 72 cm from the marker band.There also were two kinks on the inner shaft, one at 9.5 cm and the other at 15 cm from the tip.The stent was not returned for evaluation.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 cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
Event or Problem Description
It was reported that stent shortening occurred.Vascular access was obtained via a contralateral approach.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery (sfa).A 6 mm - 180 mm/130 cm innova stent was advanced to the target lesion and deployed.However, stent shortening occurred, thus another 6 mm - 100 mm/130 cm innova stent was placed to complete the procedure.No patient complications were reported and the patient¿s status was stable.
Additional Manufacturer Narrative
Updated: describe event or problem.(b)(4).
Event or Problem Description
It was further reported that during the procedure, predilation was performed.The thumbwheel was used with normal force until the white arrow was visible.Then the pull grip was used to deploy the stent.Another 6x100x130 innova¿ stent was placed overlapping the previously placed 6x180x130 innova¿ stent.

• 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: 6323518
• Report Number: 2134265-2017-00829
• Device Sequence Number: 442727
• Product Code: NIP
• UDI-Device Identifier: 08714729874058
• UDI-Public: (01)08714729874058(17)20190531(10)0019267183
• Combination Product (Y/N): N
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2017

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: 05/31/2019
• Device Model Number: H74939293061830
• Device Catalogue Number: 39293-06183
• Device Lot Number: 0019267183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2017
• Supplement Report FDA Received Date: 02/27/2017
• 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: GUIDEWIRE: 035GW; INTRODUCER SHEATH: 6F DESTINATION
• Outcome Attributed to Adverse Event: Required Intervention