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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 H7493925120400
Device Problems Stent; Bent; Failure to Advance; Physical Resistance; Catheter
Event Date 06/11/2015
Event Type  Malfunction  
Event Description

It was reported that stent damage occurred. The target lesion was located in the heavily calcified left anterior descending (lad) artery and left main (lm) artery. A 20mmx4. 00mm promus premier¿ stent was advanced but failed to cross the lesion. Upon withdrawal, resistance was encountered from the guiding catheter. When the device was removed, it was not noted that the proximal part of the stent was deformed. The procedure was completed with a 20mmx4. 00mm synergy¿ stent. No patient complications were reported and the patient's status was stable.

 
Manufacturer Narrative

(b)(4). Age at 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 and microscopic examination found that the stent was damaged at its proximal end. The struts were raised and misaligned. This type of damage is consistent with the stent meeting resistance during the withdrawal of the device. The balloon was visually and microscopically examined and no issues were noted with its profiles that could have potentially contributed to the complaint incident. The investigator noted that all the balloon folds were present. The balloon was tightly wrapped, folded evenly and was not subjected to positive pressure. A visual and microscopic examination found no issue with the profile of the devices markerbands. A visual and tactile examination found no issue with the shaft polymer extrusion profile. A visual and tactile examination of the hypotube profile found no kinks or damage along its length. 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 has been determined to be use/user error as the dfu states: "do not attempt to pull an unexpanded stent back into the guide catheter, as stent or coating damage or stent dislodgment from the balloon may occur. ¿ the recommended method for stent system removal is as follows: ¿the stent system and the guide catheter should be pulled back as a single unit until the tip of the guide catheter is just distal to the arterial sheath, allowing the guide catheter to straighten. Carefully retract the un-deployed stent into the tip of the guide catheter and remove the stent system and the guide catheter from the patient again as a single unit while leaving the guide wire across the lesion. ¿ (b)(4).

 
Event Description

It was reported that stent damage occurred. The target lesion was located in the heavily calcified left anterior descending (lad) artery and left main (lm) artery. A 20mmx4. 00mm promus premier¿ stent was advanced but failed to cross the lesion. Upon withdrawal, resistance was encountered from the guiding catheter. When the device was removed, it was not noted that the proximal part of the stent was deformed. The procedure was completed with a 20mmx4. 00mm synergy¿ stent. No patient complications were reported and the patient's status was stable.

 
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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 Key4903526
Report Number2134265-2015-04229
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/12/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/09/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/21/2016
Device MODEL NumberH7493925120400
Device Catalogue Number39251-2040
Device LOT Number17412548
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/02/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/14/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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