Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 SELECT; 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 SELECT; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number H7493939916250
Device Problems Device Damaged Prior to Use (2284); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/04/2018
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.(b)(4).
 
Event Description
It was reported that stent damage occurred.After unpacking, the physician noticed that the struts of the 2.50 x 16mm promus premier select stent were bent outwards.Another promus premier select stent was used to complete the procedure.There were no patient complications.
 
Event Description
It was reported that stent damage occurred.After unpacking, the physician noticed that the struts of the 2.50 x 16mm promus premier select stent were bent outwards.Another promus premier select stent was used to complete the procedure.There were no patient complications.
 
Manufacturer Narrative
Device evaluated by mfr., eval summary attached, method codes, result codes, and conclusion codes: updated.Device evaluated by mfr: promus premier select ous mr 2.50 x 16mm stent delivery system was returned for analysis.A visual examination of the crimped stent identified damage.Proximal struts 1 and 2 were lifted and bent back in a distal direction.The remainder of the stent was undamaged.The crimped stent outer diameter was measured and the result were within max crimped stent profile measurement.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination of the device revealed multiple hypotube kinks.An examination of the inner and outer shaft polymer extrusion found no issues.The bi-component bond showed no signs of damage or strain.The tip was visually examined and no issues found.No other issues were identified during the product analysis.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PROMUS PREMIER SELECT
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
MDR Report Key7727251
MDR Text Key115363636
Report Number2134265-2018-06706
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/14/2020
Device Model NumberH7493939916250
Device Lot Number21770631
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2018
Date Manufacturer Received08/03/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-