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

Model Number H74939295601510

Device Problems Bent (1059); Fracture (1260); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported the stent was partially deployed.During the deployment of an eluvia¿ drug-eluting vascular stent system, approximately 3-4 centimeters were deployed when the thumbwheel got stuck.The physician had to perform a traction in order to withdraw the sheath.No patient complications were reported.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the lesion was accessed using a contralateral approach.The lesion was heavily calcified and tortuous.After a non bsc guide sheath and guidewire were advanced the lesion was predilated.During deployment of the eluvia stent, it was noted the stent elongated and fractured.The stent was able to be fully deployed inside the patient with no further intervention need.No patient complications were reported and the patient status was stable.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of an eluvia sds with an unidentified.035¿ guidewire and non-bsc guide sheath.The stent was not returned for analysis.The shaft was examined.The middle shaft was buckled 3mm from the markerband.The outer sheath was separated 37cm from the nose cone but remained on the middle sheath.The separated edges were jagged which may have been caused by attempting to cut the outer shaft.The middle sheath had cut marks/damage 37cm-43cm from the nose cone.There was no evidence of any product quality deficiencies.There was a kink at the nose cone.The rack inside the handle was loose.The handle was opened during analysis.The proximal inner and middle sheath were separated from the retainer clip.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was further reported that the lesion was accessed using a contralateral approach.The lesion was heavily calcified and tortuous.After a non bsc guide sheath and guidewire were advanced the lesion was predilated.During deployment of the eluvia stent, it was noted the stent elongated and fractured.The stent was able to be fully deployed inside the patient with no further intervention need.No patient complications were reported and the patient status was stable.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the lesion was accessed using a contralateral approach.The lesion was heavily calcified and tortuous.After a non bsc guide sheath and guidewire were advanced the lesion was predilated.During deployment of the eluvia stent, it was noted the stent elongated and fractured.The stent was able to be fully deployed inside the patient with no further intervention need.No patient complications were reported and the patient status was stable.

Manufacturer Narrative

Updated: patient age at time of event : (b)(6) years old.(b)(4).

Event Description

It was further reported the target lesion was an occlusion in the superficial femoral artery (sfa).

• Brand Name: ELUVIA¿ DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6123100
• MDR Text Key: 60762108
• Report Number: 2134265-2016-11011
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: H74939295601510
• Device Catalogue Number: 39295-60151
• Device Lot Number: 19405926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1