MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER?; STENT, CORONARY, DRUG-ELUTING

Model Number H7493952824220

Device Problems Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2014

Event Type  Injury  

Event Description

It was reported that stent movement on balloon and deployment issue occurred.The target lesion was located in the mid left anterior descending artery.An emerge balloon catheter was advanced to the lesion for predilation and the balloon was inflated 3 times.The balloon catheter was removed successfully and a 2.25x12mm promus premier¿ stent was advanced but was unable to cross the lesion.The device was removed then a 2.25x24mm promus premier¿ stent was advanced however it was noted that the stent was about to be dislodged from the stent delivery system (sds) balloon.The device was already in the target lesion so the stent was deployed however, the stent would not fully appose to the vessel wall so a 2x15mm nc quantum balloon catheter was used to fully appose the stent.The 2x15mm nc quantum balloon catheter was removed and the procedure was completed.No patient complications were reported.

Manufacturer Narrative

Device is combination product.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

• Brand Name: PROMUS PREMIER?
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4355352
• MDR Text Key: 5143308
• Report Number: 2134265-2014-08332
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• 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: 12/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2016
• Device Model Number: H7493952824220
• Device Catalogue Number: 39528-2422
• Device Lot Number: 17331124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2014
• 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
• Patient Outcome(s): Required Intervention