• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER¿ STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number H7493925116400
Device Problems Stent; Bent; Physical Resistance; Catheter
Event Date 06/03/2015
Event Type  Malfunction  
Event Description

It was reported that stent damage occurred. Following the advancement of a guidezilla guide wire, a 16 x 4. 00 promus premier¿ drug eluting stent was used but failed to advance inside the guide wire due to resistance. The device was removed and it was noted that the stent was lifted. No patient complications were reported and the patient's status was good.

 
Manufacturer Narrative

(b)(4). Age time of event: 18 years or older. Device is a combination product. (b)(4).

 
Manufacturer Narrative

Device evaluated by mfr: the stent delivery system (sds) was returned for analysis. A visual examination of the crimped stent found the stent had moved distally on balloon and the crimped stent was damaged along its entire length with stretching of the stent evident during examination. The bumper tip of the device showed no signs of damage. The balloon cone profiles were reviewed and no issues were noted with the overall balloon profile. The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure. The stent was found to have moved distally on the balloon out over the distal markerband, however there was no apparent issues with the balloon. A visual and tactile examination found multiple kinks along the hypotube shaft. This type of damage is consistent with excessive force being applied to the delivery system. A visual and tactile examination found no issues with the shaft profile. No difficulties were experienced tracking the device over a 0. 014" guidewire. No other issues were identified during the product 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).

 
Event Description

It was reported that stent damage occurred. Following the advancement of a guidezilla guide wire, a 16 x 4. 00 promus premier⠄rug eluting stent was used but failed to advance inside the guide wire due to resistance. The device was removed and it was noted that the stent was lifted. No patient complications were reported and the patient's status was good.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROMUS PREMIER¿
Type of DeviceSTENT, 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 Key4887463
Report Number2134265-2015-03975
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor,COMPANY REPRESENT
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/03/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/02/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/11/2016
Device MODEL NumberH7493925116400
Device Catalogue Number39251-1640
Device LOT Number17606812
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/08/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/26/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-