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

Model Number H74939238601570

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).Device is a combination product.(b)(4).

Event Description

Same case as mdr id 2134265-2016-09408.(b)(6).The subject was enrolled and the index procedure was performed on (b)(6) 2016.The target lesion located in the right mid superior femoral artery (sfa) with 100% stenosis and was 190 mm long with a reference vessel diameter (proximal 5.0 mm; distal 4.5 mm) and was classified as tasc ii c lesion.The target lesion was treated with pre-dilatation and placement of two 6.0 x 150mm eluvia drug-eluting vascular stents.Following post-dilatation, residual stenosis was 10%.The 6.0 x 150 mm eluvia drug-eluting vascular stents (lot 18822230) was advanced to the distal target lesion and was noted that the stent was kinked or deformed stent.The delivery system was attempted to be removed and was pulled forcibly.The stent was noted to be fractured.The second 6.0 x 150 mm study stent with (lot 18822232) was advanced to the target lesion and was noted that the stent was kinked or deformed stent.The delivery system was attempted to be removed and was pulled forcibly.The stent was noted to be fractured and the deployment wheel was broken.The procedure did not lead to a serious adverse event.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an eluvia stent delivery system (sds) with a.014¿ guidewire.The guidewire was in the lumen of the sds.The proximal end was 113.5 cm from the handle and 27.5cm from the tip.The stent was not returned.There were kinks in the shaft at the distal end of nose cone and at the proximal edge of the markerband.The handle was opened during analysis and found a kink at the clip as well as the inner prolapse in the rack.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.There was blood in the lumens.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 during deployment of second stent (b)(4), a non-bsc.014 guide wire was advanced from distal using wire rendez-vous technique and became entrapped in the fractured stent.A 5mm portion of the guide wire remained in the vessel.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the stent fracture was noted only for stent (18822232) and not for stent (18822230).

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that both stents (18822232) and (18822230) appeared fractured during six month follow up visit.

• Brand Name: ELUVIATM 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: 6017735
• MDR Text Key: 57041162
• Report Number: 2134265-2016-09409
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H74939238601570
• Device Catalogue Number: 39238-60157
• Device Lot Number: 18822232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR