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

Model Number 24657

Device Problems Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2019

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that the stent became deformed during deployment.A 7x120x130 eluvia drug-eluting vascular stent system was selected for use for a stenting procedure in the superficial femoral artery (sfa) location.During the procedure the stent did not deploy correctly, elongated and malformed.Physician crushed the stent with a balloon and putted a new stent in the patient to complete the procedure.There were no patient complications.

Event Description

It was reported that the stent became deformed during deployment.A 7x120x130 eluvia drug-eluting vascular stent system was selected for use for a stenting procedure in the superficial femoral artery (sfa) location.During the procedure the stent did not deploy correctly, elongated and malformed.Physician crushed the stent with a balloon and putted a new stent in the patient to complete the procedure.There were no patient complications.It was corrected that the device was selected for use within the femoral artery.The stent did not deploy correctly as it elongated and was not uniform during deployment.A balloon was used to 'crush' the stent and a new stent was placed.There were no patient complications.

Manufacturer Narrative

Age at time of event: 18 years or older.Adverse event/product problem was corrected from product problem to adverse event and product problem.Describe event or problem was updated for clarity.Type of reportable event was corrected from malfunction to serious injury.Device codes were corrected from 2524 and 2976 to 2976.

Event Description

It was reported that the stent became deformed during deployment.A 7x120x130 eluvia drug-eluting vascular stent system was selected for use for a stenting procedure in the superficial femoral artery (sfa) location.During the procedure the stent did not deploy correctly, elongated and malformed.Physician crushed the stent with a balloon and putted a new stent in the patient to complete the procedure.There were no patient complications.It was corrected that the device was selected for use within the femoral artery.The stent did not deploy correctly as it elongated and was not uniform during deployment.A balloon was used to 'crush' the stent and a new stent was placed.There were no patient complications.

Manufacturer Narrative

A2: age at time of event: 18 years or older.Device evaluated by manufacturer: the returned product consisted of an eluvia self-expanding stent system with a 0.014 guidewire.The returned guidewire has multiple kinks along it.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the inner liner is separated 23.9cm from the tip.The distal end of the separation is stretched and has multiple kinks.The inner liner is also separated 6.1cm from the proximal end of the clip.The inner liner is stretched at the clip.The middle sheath is separated from the retainer on the pull rack.There is buckling to the outer sheath at the nosecone, 43.9cm, 58.1cm, and 58.6cm from the nosecone.The thumbwheel is missing and did not return for product analysis.Microscopic examination revealed that the tip is damaged.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; two scimed place; maple grove MN 55311
• MDR Report Key: 9161733
• MDR Text Key: 161736456
• Report Number: 2134265-2019-12076
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 08714729876731
• UDI-Public: 08714729876731
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2020
• Device Model Number: 24657
• Device Catalogue Number: 24657
• Device Lot Number: 0023156710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 09/17/2019; 10/14/2019
• Supplement Dates FDA Received: 10/07/2019; 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention