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

Model Number	24657
Medical Device Problem Codes	Fracture (1260); Deformation Due to Compressive Stress (2889); Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Discomfort (2330); Swelling/ Edema (4577)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent partial deployment and fracture occurred requiring additional intervention.The 90% stenosed target lesion was located in the severely calcified and moderately tortuous proximal superficial femoral artery (sfa).A 7x100, 130 cm eluvia drug-eluting vascular stent system was selected for a left leg intervention.Pedal access, and angiogram was performed.Laser atherectomy of the sfa/popliteal (pop)/at vessels.Balloon angioplasty was performed post atherectomy.A perforated segment in the distal popliteal artery with angiographic evidence was noted.The eluvia stent was placed over the 014 non-boston scientific guidewire to be deployed in the proximal sfa.The physician had trouble advancing the device to the lesion location in the distal sfa/pop location.The entire segment from tpt-common femoral artery (cfa) was stented previously with in-stent restenosis (isr) effecting the entire length.When the device could not be advanced to that area for implantation, the physician decided to deploy the stent in the area of perforation, popliteal artery.The physician was advancing the stent, to the primary sfa lesion location, aggressively and the stent shaft was noted to be accordion or scrunching onto itself.Upon deploying the stent in the secondary location of the popliteal artery, the stent was pulled back and some issues occurred while trying to deploy the stent.The thumbwheel was moving like normal deployment, then aggressively clicked.The stent half deployed into the vessel with the other half still remaining in the deployment housing/shaft.The thumbwheel was free spinning.Then the physician pulled the deployment handle on the back of the device and broke it off.The physician then decided to pull on the whole device to remove it, aggressively.Once the device was removed from the body, it was noticed that half of the stent was hanging out of the device which was then removed from the shaft on the back table.An attempt was made to balloon tamponade the perforation post stent failure.The stent that remained in the patient was post dilated.The stenosis was 65% post dilation.Since the perforation was noted to be behind the knee, in the joint space, it was decided to end the procedure and send the patient to the hospital for a covered stent placement.Status of the patient is unknown at this time and date.The patient experienced discomfort, pain, hematoma, and swelling.A blood pressure cuff was place at the site of bleeding.
Additional Manufacturer Narrative
D9: device avail for evaluation? and returned to manufacturer date: updated.H3: device return to manufacturer?: updated.H6: evaluation method codes (0) and evaluation result codes (1): updated.B5: describe event or problem: additional information.Device evaluated by mfr: the returned product consisted of an eluvia self-expanding stent system.The outer sheath, tip, inner shafts, and the remainder of the device were checked for damage.Visual examination revealed multiple buckling to the outer sheath.The pull rack is separated at the handle.The proximal end of the pull rack is missing.The stent is separated 37mm from one end and the separated portion is missing.Microscopic examination revealed no damages.The handle was x-ray and the middle sheath is separated from the retainer.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis found damage that would have contributed to deployment issues and difficulty to advance.
Event or Problem Description
It was reported that stent partial deployment and fracture occurred requiring additional intervention.The 90% stenosed target lesion was located in the severely calcified and moderately tortuous proximal superficial femoral artery (sfa).A 7x100, 130 cm eluvia drug-eluting vascular stent system was selected for a left leg intervention.Pedal access, and angiogram was performed.Laser atherectomy of the sfa/popliteal (pop)/at vessels.Balloon angioplasty was performed post atherectomy.A perforated segment in the distal popliteal artery with angiographic evidence was noted.The eluvia stent was placed over the 014 non-boston scientific guidewire to be deployed in the proximal sfa.The physician had trouble advancing the device to the lesion location in the distal sfa/pop location.The entire segment from tpt-common femoral artery (cfa) was stented previously with in-stent restenosis (isr) effecting the entire length.When the device could not be advanced to that area for implantation, the physician decided to deploy the stent in the area of perforation, popliteal artery.The physician was advancing the stent, to the primary sfa lesion location, aggressively and the stent shaft was noted to be accordion or scrunching onto itself.Upon deploying the stent in the secondary location of the popliteal artery, the stent was pulled back and some issues occurred while trying to deploy the stent.The thumbwheel was moving like normal deployment, then aggressively clicked.The stent half deployed into the vessel with the other half still remaining in the deployment housing/shaft.The thumbwheel was free spinning.Then the physician pulled the deployment handle on the back of the device and broke it off.The physician then decided to pull on the whole device to remove it, aggressively.Once the device was removed from the body, it was noticed that half of the stent was hanging out of the device which was then removed from the shaft on the back table.An attempt was made to balloon tapenade the perforation post stent failure.The stent that remained in the patient was post dilated.The stenosis was 65% post dilation.Since the perforation was noted to be behind the knee, in the joint space, it was decided to end the procedure and send the patient to the hospital for a covered stent placement.Status of the patient is unknown at this time and date.The patient experienced discomfort, pain, hematoma, and swelling.A blood pressure cuff was place at the site of bleeding.It was further reported that the perforation was caused by the 014 non-boston scientific guidewire trying to cross the chronic total occlusion (cto).The hematoma was located in the popliteal artery behind the knee.The swelling was located behind the knee.The patient was transferred to a different hospital post procedure.Vascular access was gained via pedal access.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17966964
• Report Number: 2124215-2023-56924
• Device Sequence Number: 7623775
• Product Code: NIU
• UDI-Device Identifier: 08714729876724
• UDI-Public: 08714729876724
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P180011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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: 10/09/2023
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0028333382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON: 6.0X220 STERLING; BALLOON: 6.0X220 STERLING; BALLOON: CHARGER; BALLOON: CHARGER; GUIDEWIRE: 014 COMMAND WIRE; GUIDEWIRE: 014 COMMAND WIRE; SHEATH: 6FR CORDIS RADIAL SHEATH; SHEATH: 6FR CORDIS RADIAL SHEATH
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Race: White