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

Model Number	H74939293052030
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/06/2017
Type of Reportable Event	Serious Injury
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
It was reported that partial stent deployment occurred resulting in removal difficulties and patient surgery.The chronic occluded target lesion was located in the superficial femoral artery (sfa).The lesion was pre- dilated with a 4 mm x 40 mm mustang balloon catheter.The doctor advanced the 5x200x130 innova¿ contralateral over the tight aortic bifurcation all the way through the superficial femoral artery (sfa) down into the proximal popliteal.Deployment was initiated via the thumbwheel and the stent deployed up to 120mm.The physician then proceeded to use the pull grip to fully deploy the remainder of the stent.The physician thought the stent was fully deployed so the stent delivery system was attempted to be withdrawn from the patient.The physician noticed a lot of resistance and had to pull hard to try to get the delivery system out of the patient¿s body.In removal attempts the delivery system came apart.The outer layer broke and came off and the handle on the outer layer of the delivery system was removed from the body.The inner layer remained in the body on the wire but it stretched the stent.The stent stretched all the way from the proximal popliteal, all the way through the entire sfa, into the sheath which was in the iliac.The stent could not be removed.The physician tried a few different options to try to get the stent out.Eventually, the patient was sent for surgery and a femoral cut down was performed.The upper portion of the stent was removed.The indwelling sfa portion was left in the recanalized sfa.Post surgery popliteal pulse was present within the patient.No further patient complications were reported.
Additional Manufacturer Narrative
Updated: weight, weight (unit), describe event or problem , other relevant history, init reporter sent to fda.If implanted, give date: (b)(6) 2017.(b)(4).
Event or Problem Description
It was further reported that the event was reported via a voluntary medwatch # (b)(4).
Additional Manufacturer Narrative
Updated:  device avail.For eval, returned to mfr.On,  device returned to mfr., device evaluated by mfr., eval summary attached, method codes, results codes, conclusion codes.Device evaluated by mfr: returned product consisted of an innova self-expanding stent delivery system (sds).The outer shaft and the remainder of the device were checked for damage.Visual examination showed multiple kinks throughout the outer sheath.The mid-shaft separated from the device and was not returned.The proximal inner was separated from the device and not returned.The inner liner was separated from the clip and handle and had multiple kinks throughout the shaft.The stent was not returned.The pull handle was loose in the device.The handle was opened to inspect for further damage no further damage was noticed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Device evaluated by manufacturer: 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 partial stent deployment occurred resulting in removal difficulties and patient surgery.The chronic occluded target lesion was located in the superficial femoral artery (sfa).The lesion was pre- dilated with a 4 mm x 40 mm mustang balloon catheter.The doctor advanced the 5x200x130 innova¿ contralateral over the tight aortic bifurcation all the way through the superficial femoral artery (sfa) down into the proximal popliteal.Deployment was initiated via the thumbwheel and the stent deployed up to 120mm.The physician then proceeded to use the pull grip to fully deploy the remainder of the stent.The physician thought the stent was fully deployed so the stent delivery system was attempted to be withdrawn from the patient.The physician noticed a lot of resistance and had to pull hard to try to get the delivery system out of the patient¿s body.In removal attempts the delivery system came apart.The outer layer broke and came off and the handle on the outer layer of the delivery system was removed from the body.The inner layer remained in the body on the wire but it stretched the stent.The stent stretched all the way from the proximal popliteal, all the way through the entire sfa, into the sheath which was in the iliac.The stent could not be removed.The physician tried a few different options to try to get the stent out.Eventually, the patient was sent for surgery and a femoral cut down was performed.The upper portion of the stent was removed.The indwelling sfa portion was left in the recanalized sfa.Post surgery popliteal pulse was present within the patient.No further 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: 6912828
• Report Number: 2134265-2017-09516
• Device Sequence Number: 16321616
• Product Code: NIP
• UDI-Device Identifier: 08714729873976
• UDI-Public: 08714729873976
• 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): 09/06/2017

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: 04/30/2020
• Device Model Number: H74939293052030
• Device Catalogue Number: 39293-05203
• Device Lot Number: 20470018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 09/29/2017; 01/16/2018
• Initial Report FDA Received Date: 10/03/2017
• Supplement Report FDA Received Date: 10/26/2017; 02/08/2018
• 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
• Patient Weight: 37