MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY VERIFLEX?; STENT, CORONARY

Model Number H7493893412500

Device Problems Migration or Expulsion of Device (1395); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/12/2014

Event Type  Injury  

Event Description

It was reported that stent dislodgement and embolization occurred.The target lesion was located in the right coronary artery.A 5.00mm x 12mm veriflex¿ stent was advanced to the lesion but was unable to cross.It was noted that the stent was dislodged from the delivery system balloon.The dislodged stent traveled down the aorta and was left inside the patient.No further patient complications were reported and patient's status is stable.

Manufacturer Narrative

(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

• Brand Name: VERIFLEX?
• Type of Device: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3891284
• MDR Text Key: 4540362
• Report Number: 2134265-2014-03527
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2014
• Device Model Number: H7493893412500
• Device Catalogue Number: 38934-1250
• Device Lot Number: 0014824385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other