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); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)

Patient Problems Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165)

Event Date 10/12/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a vessel perforation, stent deployment issue and a stent fracture occurred.Vascular access was obtained using a contralateral approach.The highly calcified and moderately tortuous target lesion was located in the chronic total occluded superficial femoral artery.Following pre-dilation, a 6x150, 130cm eluvia¿ drug-eluting vascular stent system was advanced to the target lesion over a 0.035 guidewire.After approximately 1/3 of the stent was deployed, the stent deployment thumbwheel and pull grip did not work.The stent was attempted to be retrieved by pulling back with extreme difficulty.However, this led to the stent elongating and ultimately 3-4cm of the stent fracturing and remaining inside the patient.During the removal attempts, the patient experienced an arterial perforation.The perforation and fragmented stent piece were covered with three additional stents.No further complications were reported and the patient was discharged without significant complication.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an eluvia stent delivery system (sds).The handle was separated as received.The shaft and handle were examined.There was a buckle at the nose cone.There was a kink in the inner shaft at the distal end of the middle shaft.The stent was not returned.The sds was in the deployed state, the inner was pulled out 150mm.The tip had impressions of the stent.The first distal tooth on the rack was damaged.The middle sheath was pulled out of the retainer clip.There was no evidence of any product quality deficiencies.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 reported that a vessel perforation, stent deployment issue and a stent fracture occurred.Vascular access was obtained using a contralateral approach.The highly calcified and moderately tortuous target lesion was located in the chronic total occluded superficial femoral artery.Following pre-dilation, a 6x150, 130cm eluvia¿ drug-eluting vascular stent system was advanced to the target lesion over a 0.035 guidewire.After approximately 1/3 of the stent was deployed, the stent deployment thumbwheel and pull grip did not work.The stent was attempted to be retrieved by pulling back with extreme difficulty.However, this led to the stent elongating and ultimately 3-4cm of the stent fracturing and remaining inside the patient.During the removal attempts, the patient experienced an arterial perforation.The perforation and fragmented stent piece were covered with three additional stents.No further complications were reported and the patient was discharged without significant complication.

• 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: 6091439
• MDR Text Key: 59552444
• Report Number: 2134265-2016-09921
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: Yes
• 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: 19396993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2016
• 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
• Treatment: SHEATH: COOK 45 CM 6F STRAIGHT; TERUMO 0.035 GUIDEWIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR