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

Model Number	H74939293071830
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Age at the time of event: 18 years or older.(b)(4).
Event or Problem Description
It was reported that partial stent deployment, stent fracture and stent withdrawal difficulty occurred.The 80% stenosed target lesion was located in the moderately tortuous and non-calcified superficial femoral artery (sfa).Following pre-dilation with a coyote balloon catheter, a 7 x 180 x 130 innova¿ stent was advanced contralateral over a.035 non-bsc guidewire and stent deployment was initiated.The stent was deployed about 2cm using the thumbwheel, then it stopped releasing and the thumbwheel moved freely.The pull grip was attempted to release the stent, but this failed.The innova delivery system was slightly pushed and pulled and pulled back towards the right external iliac artery (eia).When the device came into contact with the access site, the stent was not able to be pulled inside the sheath.The delivery system was pulled and the stent fractured and detached in the distal left eia.The sheath was replaced with angioseal and forceps were used to capture the fractured stent and pull it near to the access site.A cut down was then performed on the patient and the fractured stent was removed.The procedure was aborted.There were no further patient complications and the patient status was fine post-procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: 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 outer sheath was also buckled in 2 areas.The 1st buckling was approximately 61cm from the nosecone.The 2nd area was approximately 71cm from the nosecone.The mid-shaft showed damage in the form of flattening and being creased.This damage was approximately 119 to 127cm from the nosecone.The mid-shaft was also kinked approximately 2cm from the retainer clip.The devices pull handle was loose in the handle which indicates internal damage.The thumbwheel was also loose.The handle was separated and it was noticed that the retainer clip had detached from the pull rack.The pull rack showed slight damage on the 1st tooth.The stent was returned part in the mid-shaft and part of the stent was stuck in the introducer sheath.The stent fractured when it was pulled back into the introducer sheath per the customer¿s complaint.This would contribute to the mid-shaft of the device being stuck inside of the introducer sheath when the device was returned.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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, stent fracture and stent withdrawal difficulty occurred.The 80% stenosed target lesion was located in the moderately tortuous and non-calcified superficial femoral artery (sfa).Following pre-dilation with a coyote balloon catheter, a 7 x 180 x 130 innova¿ stent was advanced contralateral over a.035 non-bsc guidewire and stent deployment was initiated.The stent was deployed about 2cm using the thumbwheel, then it stopped releasing and the thumbwheel moved freely.The pull grip was attempted to release the stent, but this failed.The innova delivery system was slightly pushed and pulled and pulled back towards the right external iliac artery (eia).When the device came into contact with the access site, the stent was not able to be pulled inside the sheath.The delivery system was pulled and the stent fractured and detached in the distal left eia.The sheath was replaced with angioseal and forceps were used to capture the fractured stent and pull it near to the access site.A cut down was then performed on the patient and the fractured stent was removed.The procedure was aborted.There were no further patient complications and the patient status was 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: 7007374
• Report Number: 2134265-2017-10602
• Device Sequence Number: 2004806
• Product Code: NIP
• UDI-Device Identifier: 08714729874140
• UDI-Public: 08714729874140
• Combination Product (Y/N): N
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2017

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: 08/31/2019
• Device Model Number: H74939293071830
• Device Catalogue Number: 39293-07183
• Device Lot Number: 0019597803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 12/05/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention