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

Model Number 24657

Device Problems Fracture (1260); Activation, Positioning or Separation Problem (2906)

Patient Problems Foreign Body In Patient (2687); Unspecified Tissue Injury (4559)

Event Date 07/18/2023

Event Type  Injury  

Event Description

It was reported that the stent partially deployed and was fractured.An eluvia us, 7x150, 130 cm was selected for use in the stenting procedure to treat the patient's peripheral artery disease.The target lesion was located in the distal superficial femoral artery (sfa) and p1 segment of the popliteal artery and was 95% stenosed with moderate tortuosity and severe calcification.The lesion was predilated using a 6f mustang ballon dilation catheter.Post dilation, the lesion was 80% stenosed.The first eluvia 7x150 was advanced over a v-18 guidewire and deployed successfully in the distal sfa and p1.The second eluvia 7x150 was advanced to the canal area, but when deployment was attempted, the stent only partially deployed.It was observed under fluoroscopy that the proximal portion of the stent had fractured at approximately 1cm.The fractured portion of the stent that remained undeployed was removed from the patient along with the delivery system.The remainder of the stent remained in the patient.A third eluvia 7x150 was attempted to be deployed to replace the previous eluvia 7x150, but the same issues occurred.A non-boston scientific stent was deployed to cover the two fractured eluvia devices that remained in target lesion.There were no reported patient complications as a result of the malfunctions.

Event Description

It was reported that the stent partially deployed and was fractured.An eluvia us, 7x150, 130 cm was selected for use in the stenting procedure to treat the patient's peripheral artery disease.The target lesion was located in the distal superficial femoral artery (sfa) and p1 segment of the popliteal artery and was 95% stenosed with moderate tortuosity and severe calcification.The lesion was predilated using a 6f mustang balloon dilation catheter.Post dilation, the lesion was 80% stenosed.The first eluvia 7x150 was advanced over a v-18 guidewire and deployed successfully in the distal sfa and p1.The second eluvia 7x150 was advanced to the canal area, but when deployment was attempted, the stent only partially deployed.It was observed under fluoroscopy that the proximal portion of the stent had fractured at approximately 1cm.The fractured portion of the stent that remained undeployed was removed from the patient along with the delivery system.The remainder of the stent remained in the patient.A third eluvia 7x150 was attempted to be deployed to replace the previous eluvia 7x150, but the same issues occurred.A non-boston scientific stent was deployed to cover the two fractured eluvia devices that remained in target lesion.There were no reported patient complications as a result of the malfunctions.It was further reported that the physician used a contralateral approach.Prior to the pre-dilation using the 6f mustang balloon dilation catheter, the physician attempted to access the target lesion using an unknown 0.035 guidewire but was unable to cross due to the amount of calcification.Following pre-dilation with the 6f mustang balloon dilation catheter, the guidewire was exchanged for the v-18.The second eluvia 7x150 was advanced to the canal area, but when deployment was attempted, the stent only partially deployed.The physician was able to pull the stent and delivery system from the patient without issue, and there were no observable kinks or damage to the device upon removal.The third eluvia 7x150 was attempted to be deployed, and the majority of the stent was deployed.The physician attempted to remove the stent in the same way as the second stent and it fractured during the device removal, leaving approximately 10mm of the stent inside the body.When this was removed, everything besides the guidewire had come out of the patient, leaving a large hole in the access site.They held manual pressure on the femoral site and placed a larger sheath in the patient and placed a non-boston scientific stent successfully.No further patient complications were reported.

Manufacturer Narrative

Device analysis: 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.The stent was partially deployed and separated 2.2cm from the distal end of the middle sheath.The returned stent measured approximately 11.7cm long.There were multiple kinks along the outer sheath.The pull rack was separated approximately 4cm from the retainer.The middle sheath was no longer attached to the retainer.Microscopic examination revealed no additional damages.The proximal end of the separated pull rack did not return for analysis.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis found damage that could have contributed to the deployment issue.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: 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: 17541262
• MDR Text Key: 321110776
• Report Number: 2124215-2023-42736
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876748
• UDI-Public: 08714729876748
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0031219147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 6F MUSTANG BALLON DILATION CATHETER; 6F MUSTANG BALLON DILATION CATHETER; ELUVIA 7X150; ELUVIA 7X150; ELUVIA 7X150; ELUVIA 7X150; V-18 GUIDEWIRE; V-18 GUIDEWIRE
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Male