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

Model Number	H74939293062030
Medical Device Problem Codes	Fracture (1260); Stretched (1601); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2017
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 a fractured stent and patient surgery.The 99% stenosed target lesion was located in a heavily calcified and little to non tortuous lesion located in the right leg.A 7 french 45cm non bsc sheath and an amplatz super stiff 260 guidewire were advanced via a contralateral approach.The lesion was pre-dilated.A 6x200x130 innova¿ stent was advanced and deployment was initiated.The stent deployed to approximately 10-20mm and deployment stopped.The physician attempted to remove the stent and delivery system together as one unit.The deployed section of the stent that was apposed to the vessel wall elongated and subsequently fractured in the removal process.A portion of the stent was caught on the sheath and broke off inside the vessel.The remainder of the stent that was contained inside the delivery device was removed.The patient was then sent to surgery to remove the fractured stent and an arterial bile patch.There were no further patient complications.The surgery was successful and the patient was in stable condition post surgery.
Additional Manufacturer Narrative
Device evaluated by manufacturer: an innova self-expanding stent delivery system (sds) was returned and the outer shaft, mid-shaft and the remainder of the device were checked for damage.Visual examination showed a kink at the nosecone.The mid-shaft showed no damage.The stent was returned in the device; however, it was partially deployed approximately 8mm from the markerband and fractured.The pull handle was loose in the device, which is an indication of the mid-shaft coming detached from the retainer clip.The handle was opened to inspect for further damage and it was noticed that the mid-shaft was detached from the retainer clip.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 occurred resulting in a fractured stent and patient surgery.The 99% stenosed target lesion was located in a heavily calcified and little to non tortuous lesion located in the right leg.A 7 french 45cm non bsc sheath and an amplatz super stiff 260 guidewire were advanced via a contralateral approach.The lesion was pre-dilated.A 6x200x130 innova stent was advanced and deployment was initiated.The stent deployed to approximately 10-20mm and deployment stopped.The physician attempted to remove the stent and delivery system together as one unit.The deployed section of the stent that was apposed to the vessel wall elongated and subsequently fractured in the removal process.A portion of the stent was caught on the sheath and broke off inside the vessel.The remainder of the stent that was contained inside the delivery device was removed.The patient was then sent to surgery to remove the fractured stent and an arterial bile patch.There were no further patient complications.The surgery was successful and the patient was in stable condition post surgery.

• 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: 6842829
• Report Number: 2134265-2017-08827
• Device Sequence Number: 761188
• Product Code: NIP
• UDI-Device Identifier: 08714729874065
• UDI-Public: (01)08714729874065(17)20191231(10)20109861
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/16/2017

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: 12/31/2019
• Device Model Number: H74939293062030
• Device Catalogue Number: 39293-06203
• Device Lot Number: 20109861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Initial Date Received by Manufacturer: 08/16/2017
• Supplement Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7FR 45CM TERUMO DESTINATION SHEATH; GUIDEWIRE: BSC AMPLATZ SUPER STIFF 260
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR