MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number 24653

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/29/2019

Event Type  malfunction  

Event Description

It was reported that a partial stent deployment occurred.A 6 x 120 x 75 eluvia drug-eluting vascular stent system was selected for a procedure in the superficial femoral artery (sfa).The lesion was pre-dilated.During stent placement in the sfa, the stent partially deployed.The delivery system did not fully release the stent.The physician manually released the stent by taking apart the handle.The stent was fully released.The procedure was completed with this device and there were no patient complications reported.

Event Description

It was reported that a partial stent deployment occurred.A 6x120x75 eluvia drug-eluting vascular stent system was selected for a procedure in the superficial femoral artery (sfa).The lesion was pre-dilated.During stent placement in the sfa, the stent partially deployed.The delivery system did not fully release the stent.The physician manually released the stent by taking apart the handle.The stent was fully released.The procedure was completed with this device and there were no patient complications reported.It was further reported reported that the lesion was a long sfa occlusion.The sfa had normal tortuosity and the lesion was partly calcification.The lesion was pre-dilated.The delivery system did not work after 1.5cm of the eluvia stent was deployed in the vessel.After that, the physician heard a strange noise in the handle and the thumbwheel was spinning without deploying the rest of the stent.The physician was able to manually release the stent by disassembling the handle and forcing and stretching the delivery system with opposite movements.The stent fully released without elongating and nothing remained in the delivery system.Post dilatation, the result was angiographically satisfying.There were no patient complications.

Event Description

It was reported that a partial stent deployment occurred.A 6x120x75 eluvia drug-eluting vascular stent system was selected for a procedure in the superficial femoral artery (sfa).The lesion was pre-dilated.During stent placement in the sfa, the stent partially deployed.The delivery system did not fully release the stent.The physician manually released the stent by taking apart the handle.The stent was fully released.The procedure was completed with this device and there were no patient complications reported.It was further reported reported that the lesion was a long sfa occlusion.The sfa had normal tortuosity and the lesion was partly calcification.The lesion was pre-dilated.The delivery system did not work after 1.5cm of the eluvia stent was deployed in the vessel.After that, the physician heard a strange noise in the handle and the thumbwheel was spinning without deploying the rest of the stent.The physician was able to manually release the stent by disassembling the handle and forcing and stretching the delivery system with opposite movements.The stent fully released without elongating and nothing remained in the delivery system.Post dilatation, the result was angiographically satisfying.There were no patient complications.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an eluvia self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the handle was open.There was a kink to the proximal inner which appeared to look like it started to prolapse.The outer sheath appeared to be twisted 4.2cm from the nosecone.There are pry marks on the top section of the handle.Microscopic examination revealed damage to approximately half of the teeth on the thumbwheel.There was damage to two teeth on the pull rack approximately 19cm from the knob.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis found damage on the device that is consistent with deployment issues.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8901382
• MDR Text Key: 154556748
• Report Number: 2134265-2019-09781
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023605759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Date Manufacturer Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TERUMO .035 GUIDEWIRE; TERUMO .035 GUIDEWIRE; TERUMO LONG SHEATH; TERUMO LONG SHEATH