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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER SELECT; STENT, CORONARY, DRUG-ELUTING
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BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER SELECT; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 10663
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/07/2018
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that an issue occurred during the preparation of a percutaneous coronary intervention.As the physician was prepping the 16 x 2.75 promus premier select when the delivery system of the stent broke apart into two pieces in the doctor's hands.This occurred outside the patient and thus no patient harm occurred.An alternative method was used to complete the procedure without issues.
 
Event Description
It was reported that an issue occurred during the preparation of a percutaneous coronary intervention.As the physician was prepping the 16 x 2.75 promus premier select when the delivery system of the stent broke apart into two pieces in the doctor's hands.This occurred outside the patient and thus no patient harm occurred.An alternative method was used to complete the procedure without issues.Promus premier select ous mr 2.75 x 16 mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal markerbands.The crimped stent od (outer diameter) was measured and was within specifications.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.The hypotube was found broke 758 mm distal from the distal end of the strain relief.Multiple hypotube kinks were also noted.No issues were found with the shaft polymer extrusion or the bumper tip.
 
Manufacturer Narrative
Device is a combination product.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/17/2018 04:05 pm ct.The report number is being corrected from: 2134265-2018-64431 to: 2134265-2018-63403.
 
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Brand Name
PROMUS PREMIER SELECT
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8130682
MDR Text Key129310415
Report Number2134265-2018-63403
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/09/2020
Device Model Number10663
Device Catalogue Number10663
Device Lot Number0022145073
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2018
Date Manufacturer Received12/11/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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