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

Model Number	H74939293062030
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	06/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluation by manufacturer: 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
It was reported that partial deployment occurred.The 100% stenosed target lesion was located in the highly calcified left popliteal and superficial femoral artery.A 45cm 6f non bsc guiding sheath and a 300cm v-18 guidewire were inserted and advanced into position.Pre-dilation was performed using a 4mmx150mm sterling balloon.The 6x200x130mm innova¿ stent was introduced via a contralateral approach then advanced and deployment was initiated via the deployment thumbwheel.Stent deployment stopped after 30mm of the stent was unsheathed.The thumbwheel broke and the pull grip was unable to unsheathe the stent.The stent was then pulled back into the guiding sheath, the stent stretched and the devices were removed together.A.035mm stiff guidewire was then advanced and the procedure was completed with another 6x200x130mm innova¿ stent.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of an innova self-expanding stent delivery system (sds) stuck in an introducer sheath.The outer shaft and the remainder of the device were checked for damage.Visual examination showed a kink at the nosecone.The stent was returned in the device and partially deployed outside of the distal end of the introducer sheath as well as the tip of the device.The stent showed damage.The thumbwheel was loose.The pull handle was loose in the handle which is an indication of internal handle damage.The handle was opened to inspect for further damage.It was noticed that the mid-shaft had detached/broke at the retainer clip.No damage was noticed to the proximal inner or the inner liner.Inspection of the remainder of the device, apart from the observed damage, 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 (b)(4).
Event or Problem Description
It was reported that partial deployment occurred.The 100% stenosed target lesion was located in the highly calcified left popliteal and superficial femoral artery.A 45cm 6f non bsc guiding sheath and a 300cm v-18 guidewire were inserted and advanced into position.Pre-dilation was performed using a 4mmx150mm sterling balloon.The 6x200x130mm innova¿ stent was introduced via a contralateral approach then advanced and deployment was initiated via the deployment thumbwheel.Stent deployment stopped after 30mm of the stent was unsheathed.The thumbwheel broke and the pull grip was unable to unsheathe the stent.The stent was then pulled back into the guiding sheath, the stent stretched and the devices were removed together.A.035mm stiff guidewire was then advanced and the procedure was completed with another 6x200x130mm innova¿ stent.No patient complications were reported.

• 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: 6724352
• Report Number: 2134265-2017-07081
• Device Sequence Number: 13673626
• Product Code: NIP
• UDI-Device Identifier: 08714729874065
• UDI-Public: (01)08714729874065(17)20190930(10)19709446
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2017

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: 09/30/2019
• Device Model Number: H74939293062030
• Device Catalogue Number: 39293-06203
• Device Lot Number: 19709446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Initial Date Received by Manufacturer: 06/28/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 92169170-FA
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: V-18; SHEATH: 6FR TERUMO 45