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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number H7493918412250
Device Problems Stent (515); Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/02/2016
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 dislodgement occurred. The target lesion was located in the severely tortuous and severely calcified right coronary artery (rca). A 2. 50x12mm promus element¿ plus drug-eluting stent was advanced but failed to cross the lesion. It was then noted that the stent was dislodged from the delivery system. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable.

 
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Brand NamePROMUS ELEMENT¿ PLUS
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 Key6194829
MDR Text Key62985559
Report Number2134265-2016-12358
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeCN
PMA/PMN NumberP110010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 12/15/2016
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 EXPIRATION Date06/05/2017
Device MODEL NumberH7493918412250
Device Catalogue Number39184-1225
Device LOT Number18732821
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 Received12/15/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/10/2016
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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