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

Model Number	H74939293051530
Medical Device Problem Codes	Stretched (1601); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2018-07262.It was reported that partial stent deployment occurred.The target lesion was located in the heavily calcified popliteal artery.A 5 x 150 x 130 innova¿ was selected for use and deployment attempted.Only a partial amount of the stent deployed from the delivery system.The delivery system with stent was removed from the patient.The physician then chose another 5 x 150 x 130 innova¿ and deployment was attempted; however, the same thing occurred.The procedure was completed with angioplasty only.There were no patient complications and the patient condition post-procedure was fine.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that the target lesion was over 90% stenosed and not too severely calcified.Vascular access was obtained via a contralateral approach.The lesion was pre-dilated.The first 5 x 150 x 130 innova was advanced over a.014 guidewire.The second 5 x 150 x 130 innova was advanced over a.035 guidewire.
Additional Manufacturer Narrative
Describe event or problem, other relevant history, device codes: updated.(b)(4).
Event or Problem Description
It was further reported that the deployment thumbwheel became increasingly more difficult as deployment was initiated.The pull grip eventually disconnected due to the high forces required.This stent was extremely stretched upon removal.The patient's calcification and disease was descried as very difficult and 'hard as a rock'.The physician did assess this as being a factor in the procedure.The patient was confirmed to be fine.No complications.

• 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: 7771927
• Report Number: 2134265-2018-07263
• Device Sequence Number: 1118775
• Product Code: NIP
• UDI-Device Identifier: 08714729873952
• UDI-Public: 08714729873952
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2018

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: 05/31/2021
• Device Model Number: H74939293051530
• Device Catalogue Number: 39293-05153
• Device Lot Number: 0022195229
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 07/26/2018; 09/05/2018
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 08/17/2018; 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1