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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 H7493925116300
Device Problems Stent (515); Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2016
Event Type  Injury  
Manufacturer Narrative

Age at time of event: 18 years or older. Device is a combination product. (b)(4). Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted. If there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).

 
Event Description

It was reported that stent fracture occurred. The target lesion was located in the tortuous and non calcified proximal right coronary artery (rca) which was across a large hinge point. In (b)(6) 2016, a 3. 00x16mm promus premier¿ drug-eluting stent was implanted to treat the lesion. In (b)(6) 2016, the patient returned to the hospital and the angiogram showed that the previously implanted 3. 00x16mm promus premier¿ stent was broken in the center of the hinge point of the vessel. The broken stent was successfully crossed and opened with a balloon catheter and a 3. 5x15mm non-bsc stent was implanted to open up the previous placed promus premier stent. The case was successfully completed and the patient was discharged. No further 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
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6194761
MDR Text Key62993395
Report Number2134265-2016-12204
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeAU
PMA/PMN NumberP110010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 12/14/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberH7493925116300
Device Catalogue Number39251-1630
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 12/21/2016 Patient Sequence Number: 1
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