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

Model Number 24653

Device Problems Difficult or Delayed Positioning (1157); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that stent elongation occurred.The 100% stenosed, focal target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery (sfa).Following pre-dilation with a non-bsc balloon, a 6 x 120 x 130 eluvia drug-eluting vascular stent system was advanced contralateral over a.014 unknown guidewire and deployed with no issues.A second 6 x 120 x 130 eluvia drug-eluting vascular stent system was then selected and advanced to the lesion.During stent deployment, movement of the thumbwheel was not good from the beginning.For the remaining 4-5cm, the thumbwheel became considerably hard.The thumbwheel was rotated with force and was able to place the stent.However, the stent became elongated.A third eluvia drug-eluting vascular stent system (7x40) was placed over a.035 guidewire and stent deployment was completed without any problems.The procedure was concluded.There were no patient complications.

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.Device evaluated by mfr: returned product consisted of an eluvia self-expanding stent system with a 0.014" guidewire stuck in the device.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the yellow thumbwheel lock and luer was missing.The stent was deployed.There was a kink on the outer sheath at the nosecone.The guidewire was sticking out 24.5cm from the tip and 34cm from the pull rack.The pull rack measured 15.6cm from the handle to the knob.Microscopic examination did not reveal any damages.There was blood present inside the middle sheath and the middle sheath appears cloudy.Operations engineering opened the handle and the proximal inner appears to have prolapsed.Inspection of the remainder of the device, revealed no other damage or irregularities.

Event Description

It was reported that stent elongation occurred.The 100% stenosed, focal target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery (sfa).Following pre-dilation with a non-bsc balloon, a 6 x 120 x 130 eluvia drug-eluting vascular stent system was advanced contralateral over a.014 unknown guidewire and deployed with no issues.A second 6 x 120 x 130 eluvia drug-eluting vascular stent system was then selected and advanced to the lesion.During stent deployment, movement of the thumbwheel was not good from the beginning.For the remaining 4-5cm, the thumbwheel became considerably hard.The thumbwheel was rotated with force and was able to place the stent.However, the stent became elongated.A third eluvia drug-eluting vascular stent system (7x40) was placed over a.035 guidewire and stent deployment was completed without any problems.The procedure was concluded.There were no patient complications.

• 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: 8450100
• MDR Text Key: 139805142
• Report Number: 2134265-2019-02710
• 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
• Report Date: 04/04/2019

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 Expiration Date: 11/18/2020
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023064517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Initial Date Manufacturer Received: 03/06/2019
• Initial Date FDA Received: 03/25/2019
• Supplement Dates Manufacturer Received: 03/29/2019
• Supplement Dates FDA Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1