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

Model Number	H74939293051530
Medical Device Problem Code	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: 2134265-2018-07263.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
Describe event or problem: updated.(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
Device evaluated by mfr.: the outer shaft, middle shaft, inner sheath and the remainder of the device were checked for damage.There was a kink at the nosecone.The stent was partially deployed approximately 4.3cm from the distal end of the markerband.The thumbwheel was rotated and the stent deployed as designed.The device was opened and inspected for any internal damage.No damage was noticed.Per the returned information the physician felt resistance and stopped the case and pulled the device from the patient which partially deployed the stent farther than normal.Inspection of the remainder of the device, revealed no other damage or irregularities.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.The innova dfu states that a stiff 0.035 in guidewire is strongly recommended for deployment of the stent, especially for tortuous anatomy and contralateral approaches.Use of undersized guidewires may lead to insufficient support of the device which can compromise stent delivery.This stent was used with a.014 wire.
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.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: 7771926
• Report Number: 2134265-2018-07262
• Device Sequence Number: 11250390
• 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: 05/13/2021
• Device Model Number: H74939293051530
• Device Catalogue Number: 39293-05153
• Device Lot Number: 0022112677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• 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