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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 H7493925138350
Device Problems Stent; Bent; Physical Resistance; Catheter
Event Date 06/19/2015
Event Type  Malfunction  
Event Description

It was reported that stent damage occurred. The 90% stenosed target lesion was located in a moderately tortuous and severely calcified vessel. A 38mmx3. 50mm promus premier¿ stent was inserted into a non-bsc guide catheter, however, resistance was encountered. When the device was removed from the patient, it was noted that the edge of the stent was lifted. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was good.

 
Manufacturer Narrative

Age at time of event: 18 years or older. Device is a combination product. Device evaluated by mfr: the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (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 stent struts at the distal edge and the proximal edge were damaged, distorted and lifted upwards from the stent profile. 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. 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 and may have occurred during advancement attempts to the lesion site. A visual and tactile examination found no issues with the shaft polymer extrusion profile. 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. The 90% stenosed target lesion was located in a moderately tortuous and severely calcified vessel. A 38mmx3. 50mm promus premiertent was inserted into a non-bsc guide catheter, however, resistance was encountered. When the device was removed from the patient, it was noted that the edge of the stent was lifted. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was good.

 
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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 Key4918947
Report Number2134265-2015-04433
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 06/19/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/16/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/26/2015
Device MODEL NumberH7493925138350
Device Catalogue Number39251-3835
Device LOT Number16936923
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/31/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/12/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/16/2015 Patient Sequence Number: 1
Treatment
BALLOON CATHETER: SAPPHIRE
GUIDING CATHETER: LAUNCHER
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