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

Model Number	H74939293062030
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Stretched (1601); Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that deployment difficulties, stent damage/fracture, and removal difficulties occurred.The 70% stenosed target lesion was located in the normally tortuous and moderately calcified superficial femoral artery(sfa).The lesion was not pre-dilated.A 6 x 200 x 130 innova¿ stent was advanced over a.035 guidewire contralateral to the target lesion and stent deployment was initiated.After approximately 70% of the stent was deployed, the deployment thumbwheel and pull-grip stopped working.After a few unsuccessful attempts to get the deployment mechanism working, the physician pulled back on the stent delivery system and the stent moved and stretched from the distal sfa all the way to the femoral artery.The stent was deployed in the common femoral - external iliac area.The proximal part of the stent broke.The delivery system and wire were unable to removed from the 45cm introducer sheath initially.Access was gained antegrade on the left side, and the physician was able to advance a non-bsc stent to the target lesion and deploy this stent.The physician was eventually able to remove the stent delivery system, wire, and sheath together from the right side and the procedure was completed.The patient was being brought back later that same day to cover the innova stent.There were no further patient complications and the patient is fine post-procedure.
Additional Manufacturer Narrative
Examination of the returned complaint device revealed an innova self-expanding stent delivery system (sds) was returned with an introducer sheath and a.035 guidewire stuck inside of the sheath.The outer shaft, mid-shaft, inner shaft, proximal liner and the remainder of the device were checked for damage.Visual examination showed 3 kinks on the outer sheath, the 1st kink was at the nose cone the 2nd kink was approximately 4cm from the nose cone and the 3rd kink was approximately 9.5cm from the nosecone.There was no other damage on the outer sheath.The mid-shaft was separated from the retainer clip.The inner liner was separated from the device and stuck on the guidewire.The handle was separated during investigation to visually inspect inside for further damage.There was no further damage on the inside of the handle.The pull-rack was extended to the furthest travel.The stent was not returned with the device.The sheath that was returned was x-rayed to see what was inside.It was noticed that the tip was stuck in the sheath.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 was unable to be determined.Bsc id#: (b)(4).Tw#: (b)(4).
Event or Problem Description
It was reported that deployment difficulties, stent damage/fracture, and removal difficulties occurred.The 70% stenosed target lesion was located in the normally tortuous and moderately calcified superficial femoral artery(sfa).The lesion was not pre-dilated.A 6 x 200 x 130 innova¿ stent was advanced over a.035 guidewire contralateral to the target lesion and stent deployment was initiated.After approximately 70% of the stent was deployed, the deployment thumbwheel and pull-grip stopped working.After a few unsuccessful attempts to get the deployment mechanism working, the physician pulled back on the stent delivery system and the stent moved and stretched from the distal sfa all the way to the femoral artery.The stent was deployed in the common femoral - external iliac area.The proximal part of the stent broke.The delivery system and wire were unable to removed from the 45cm introducer sheath initially.Access was gained antegrade on the left side, and the physician was able to advance a non-bsc stent to the target lesion and deploy this stent.The physician was eventually able to remove the stent delivery system, wire, and sheath together from the right side and the procedure was completed.The patient was being brought back later that same day to cover the innova stent.There were no further patient complications and the patient is fine post-procedure.

• 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: 6726535
• Report Number: 2134265-2017-07069
• Device Sequence Number: 16389560
• Product Code: NIP
• UDI-Device Identifier: 08714729874065
• UDI-Public: (01)08714729874065(17)20200229(10)20342627
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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,Followup
• Report Date (Section B): 06/23/2017

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: 02/29/2020
• Device Model Number: H74939293062030
• Device Catalogue Number: 39293-06203
• Device Lot Number: 20342627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Initial Date Received by Manufacturer: 06/23/2017
• Supplement Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 08/17/2017
• 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