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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER¿ STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number H7493952824400
Device Problems Shaft (955); Break (1069); Entrapment of Device (1212); Catheter (3038)
Patient Problem No Patient Involvement (2645)
Event Date 12/02/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that catheter entrapment and shaft break occurred. During preparation, a 4. 00x24mm promus premier¿ drug-eluting stent was advanced over 014 thruway guide wire to treat the lesion. However, the stent delivery system (sds) became stuck on the wire. When the physician attempted to remove the sds from the guidewire, the stent catheter broke. The guidewire and the sds were removed together. The procedure was completed with another thruway guidewire and another promus premier¿ stent. No patient complications were reported.

 
Manufacturer Narrative

Device evaluated by mfr: stent delivery system (sds) was returned for analysis. A visual examination of the stent found no issues on the stent. There were no signs 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 distal edge of the bumper tip of the device showed signs of damage. This type of damage is consistent with excessive force being applied to the delivery system. The balloon body was reviewed and no issues were noted with the overall balloon. The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure. 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 of the outer and mid-shaft section found a break in the port exchange site. The outer extrusion section of the port site was stretched for 3. 3cm before breaking. Inner extrusion damage 2mm distal of bi-component weld was also noted. There was evidence of medium inside the inner/outer lumen. The distal section of the delivery system was detached and returned loaded on guidewire. As part of the analysis, the 0. 014'' guidewire was removed from the distal end of the device with no restriction noted. The bi-component bond showed no signs of damage or strain. 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 root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty. (b)(4).

 
Event Description

It was reported that catheter entrapment and shaft break occurred. During preparation, a 4. 00x24mm promus premier¿ drug-eluting stent was advanced over 014 thruway guide wire to treat the lesion. However, the stent delivery system (sds) became stuck on the wire. When the physician attempted to remove the sds from the guidewire, the stent catheter broke. The guidewire and the sds were removed together. The procedure was completed with another thruway guidewire and another promus premier¿ stent. No patient complications were reported.

 
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Brand NamePROMUS PREMIER¿
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6190923
MDR Text Key62915769
Report Number2134265-2016-11778
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP110010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/02/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/20/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/18/2017
Device MODEL NumberH7493952824400
Device Catalogue Number39528-2440
Device LOT Number19197446
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/14/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/10/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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