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

Model Number	H74939293076030
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluated by manufacturer: returned product consisted of an innova self-expanding stent delivery system (sds) and no other devices.The outer sheath, middle shaft, inner liner and the remainder of the device were examined for damage.The shaft showed a kink at the nosecone.There was no damage to the mid-shaft.The inner liner was kinked approximately 4cm from the tip.No additional damage was noticed.The stent was not returned in the device.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
Same case as mdr id:2134265-2017-04811.It was reported two stents failed to expand.The 90% stenosed target lesion was located in the mildly tortuous, severely calcified external iliac artery.Using a contralateral approach, the physician advanced a 7 x 60 x 130 innova stent and deployed but failed to expand.A second 7 x 40 x 75 innova stent was then advanced and deployed but also failed to expand.The physician was able to complete the procedure by post dilating the stents with balloon angioplasty.No further complications were reported and the patient's condition 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: 6579194
• Report Number: 2134265-2017-04810
• Device Sequence Number: 13711198
• Product Code: NIP
• UDI-Device Identifier: 08714729874096
• UDI-Public: (01)08714729874096(17)20190630(10)19399361
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/25/2017

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: 06/30/2019
• Device Model Number: H74939293076030
• Device Catalogue Number: 39293-07603
• Device Lot Number: 19399361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2017
• Initial Report FDA Received Date: 05/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention