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

Model Number	H74939293062030
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Fracture (1260); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: approximately (b)(6) years.(b)(4).
Event or Problem Description
It was reported that the partially deployed stent fractured.The target lesion was located in the 70-90% stenosed, severely calcified, and moderately tortuous right external iliac.A 6 x 200 x 130 innova¿ stent was selected for use.A contralateral approach was used to access the lesion with a 6french 45cm non-bsc sheath extended over the bifurcation and down the right common iliac.The stent was attempted to be deployed over a 0.35' non-bsc guidewire.About 4 mm of the stent was deployed before the thumbwheel stopped working.There was an abnormally high resistance when turning the thumbwheel.The physician attempted to complete deployment with the pull grip, but this also failed.The handle was opened and it was attempted to deploy the stent by pining the inner shaft and bringing the outer shaft toward the inner, but this also failed.The stent was then pulled back into the sheath leaving about a 4 mm fractured segment of the stent within the patient.The procedure was completed with a non-bsc cover stent.The cover stent was deployed through the center of the 4 mm innova segment completely covering it.There were no additional patient complications and the patient was ok.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an innova self-expanding stent delivery system (sds).The outer shaft, mid-shaft, inner shaft, proximal liner and the remainder of the device were checked for damage.The handle was separated when returned from customer.A kink was noticed at the nosecone as well as multiple kinks throughout the outer sheath.The mid-shaft and the proximal inner shaft were completely separated from the handle.The stent was returned and partially deployed from the mid-shaft approximately 1.5cm from the marker band and fractured.It was noticed that the mid-shaft was separated from the retainer clip and the clip was not returned with the device.The proximal inner was separated from the handle.The device was inspected for further damage.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
It was reported that the partially deployed stent fractured.The target lesion was located in the 70-90% stenosed, severely calcified, and moderately tortuous right external iliac.A 6 x 200 x 130 innova¿ stent was selected for use.A contralateral approach was used to access the lesion with a 6french 45cm non-bsc sheath extended over the bifurcation and down the right common iliac.The stent was attempted to be deployed over a 0.35' non-bsc guidewire.About 4 mm of the stent was deployed before the thumbwheel stopped working.There was an abnormally high resistance when turning the thumbwheel.The physician attempted to complete deployment with the pull grip, but this also failed.The handle was opened and it as attempted to deploy the stent by pining the inner shaft and bringing the outer shaft toward the inner, but this also failed.The stent was then pulled back into the sheath leaving about a 4 mm fractured segment of the stent within the patient.The procedure was completed with a non-bsc cover stent.The cover stent was deployed through the center of the 4 mm innova segment completely covering it.There were no additional patient complications and the patient was ok.

• 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: 6565056
• Report Number: 2134265-2017-04681
• Device Sequence Number: 94463
• Product Code: NIP
• UDI-Device Identifier: 08714729874065
• UDI-Public: (01)08714729874065(17)20190930(10)19682956
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Report Date (Section B): 04/21/2017

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: 09/30/2019
• Device Model Number: H74939293062030
• Device Catalogue Number: 39293-06203
• Device Lot Number: 19682956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2017
• Supplement Report FDA Received Date: 06/07/2017
• 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