MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE LIBERTÉ?; STENT, CORONARY

Model Number H7493893812500

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/03/2015

Event Type  Injury  

Event Description

It was reported that stent migration occurred.Vascular access was obtained via the radial artery.The 12x5.0mm, eccentric, de novo target lesion was located in the non-calcified bifurcation of the left anterior descending(lad) artery.A 5.00mm x 12mm liberté¿ stent was deployed to treat the target lesion.Following post-dilatation, the physician noticed that the stent had migrated from the aorta to the iliac artery and no attempt was made to retrieve the stent.The procedure was completed with another of the same device.No further patient complications were reported and the patient¿s status was stable.

Manufacturer Narrative

(b)(4).The complaint device was not received for analysis.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).

• Brand Name: LIBERTÉ?
• Type of Device: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4534929
• MDR Text Key: 5513664
• Report Number: 2134265-2015-00905
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P040016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2017
• Device Model Number: H7493893812500
• Device Catalogue Number: 38938-1250
• Device Lot Number: 17208022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2014
• 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: EBU3.0/6FR GUIDE CATHETER
• Patient Outcome(s): Other
• Patient Age: 46 YR