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

Model Number H74939295601510

Device Problems Fracture (1260); Stretched (1601); Activation, Positioning or Separation Problem (2906)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device is combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that partial deployment and stent a stent fracture occurred.A 6 x 150 x 130 eluvia¿ drug-eluting vascular stent system was selected for a stenting procedure in the superficial femoral artery (sfa).The device was advanced in a crossover maneuver and deployment was initiated.The stent was deployed 2cm very well with no issues.The thumbwheel made a flip and it ran with no resistance.At that point, the deployment of the stent did not progress any further.The physician tried to pull back the whole system and the stent elongated and fractured.There was a fragment of the eluvia¿ in the iliac vessel.A balloon expandable stent was used to re-stent over the fragment of the eluvia¿ stent.The procedure was completed.

• Brand Name: ELUVIA¿ DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6834727
• MDR Text Key: 84242788
• Report Number: 2134265-2017-08501
• 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
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2018
• Device Model Number: H74939295601510
• Device Catalogue Number: 39295-60151
• Device Lot Number: 20478563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention