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

Model Number 24657

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2023

Event Type  malfunction  

Event Description

It was reported that stent partial deployment occurred.Two 6x150, 130cm eluvia drug-eluting vascular stent systems were selected for use.During the procedure, both stents would not completely deploy.The handles, of both devices, were broken apart to pin and pull the stents for full deployment.The stents fully deployed at this point.There were no patient complications.And the patient is doing well post procedure.

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 is open.The inner liner is kinked 4.8cm from the tip.The middle sheath is kinked at the retainer and 10cm from the retainer.Microscopic examination revealed, no additional damages.The stent was deployed.And did not return for analysis.Inspection of the remainder of the device, revealed no other damage or irregularities.

Event Description

It was reported that stent partial deployment occurred.Two 6x150, 130cm eluvia drug-eluting vascular stent systems were selected for use.During the procedure, both stents would not completely deploy.The handles, of both devices, were broken apart to pin and pull the stents for full deployment.The stents fully deployed at this point.There were no patient complications and the patient is doing well post procedure.It was further reported that access was gained via ipsilateral approach.The target lesion was a difficult sub intimal with a high degree of calcification.It took hours to cross and prepare the lesion.A 0.035 inch guidewire was used.The stents exhibited stacking and an audible sound was heard in the handle prior to the rack pull.During the end of the deployment with the second stent, the stent elongated.

Manufacturer Narrative

B5: describe event or problem: additional information.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 is open.The inner liner is kinked 4.8cm from the tip.The middle sheath is kinked at the retainer and 10cm from the retainer.Microscopic examination revealed no additional damages.The stent was deployed and did not return for analysis.Inspection of the remainder of the device, revealed no other damage or irregularities.

Event Description

It was reported that stent partial deployment occurred.Two 6x150, 130cm eluvia drug-eluting vascular stent systems were selected for use.During the procedure, both stents would not completely deploy.The handles, of both devices, were broken apart to pin and pull the stents for full deployment.The stents fully deployed at this point.There were no patient complications and the patient is doing well post procedure.It was further reported that access was gained via ipsilateral approach.The target lesion was a difficult sub intimal with a high degree of calcification.It took hours to cross and prepare the lesion.A 0.035 inch guidewire was used.The stents exhibited stacking and an audible sound was heard in the handle prior to the rack pull.During the end of the deployment with the second stent, the stent elongated.

Manufacturer Narrative

Additional information added to device evaluated by mfr: further review determined that the clip was damaged.The device was reviewed, and it was concluded that the damage to the clip likely contributed to the deployment issue.As the thumbwheel was rotated, tension built up along the proximal inner and it caused the clip to start to deform.This suggests that procedural factors likely contributed to the creation of the damage that led to the deployment issue and stent deformation.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 is open.The inner liner is kinked 4.8cm from the tip.The middle sheath is kinked at the retainer and 10cm from the retainer.Microscopic examination revealed no additional damages.The stent was deployed and did not return for analysis.Inspection of the remainder of the device, revealed no other damage or irregularities.

• 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: 17021123
• MDR Text Key: 316215984
• Report Number: 2124215-2023-27208
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876625
• UDI-Public: 08714729876625
• 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,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0030059522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/30/2023
• Supplement Dates Manufacturer Received: 05/17/2023; 06/15/2023
• Supplement Dates FDA Received: 06/15/2023; 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE: 0.035 INCH STIFF GLIDE ADVANTAGE; GUIDEWIRE: 0.035 INCH STIFF GLIDE ADVANTAGE