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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE SYNERGY¿ CORONARY DRUG-ELUTING STENT

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BOSTON SCIENTIFIC - MAPLE GROVE SYNERGY¿ CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number H7493919928300
Device Problems Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ischemia (1942); Myocardial Infarction (1969); Reocclusion (1985)
Event Date 12/06/2016
Event Type  Injury  
Manufacturer Narrative

Complainant name: (b)(6). Age at the time of event: 18 years or older. Device is a combination product. 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

(b)(4) clinical study. It was reported that in-stent restenosis and myocardial infarction occurred. In (b)(6) 2013, clinical status assessment identified the patient's qualifying condition as silent ischemia. Prior to procedure, the patient was found to have abnormal stress test or imaging stress test indicative of ischemia and the subject was referred for cardiac catheterization. Index procedure was performed on the same day. Target lesion was located in the distal right coronary rca (cass site # 3) with 75% stenosis, and was 23 mm long with a reference vessel diameter of 3 mm. The target lesion was treated with pre-dilatation, placement of a 3 x 28 mm study stent. Following post-dilatation the residual stenosis was 0%. The following day, the patient was discharged on dual antiplatelet therapy. In (b)(6) 2016, the patient experienced silent myocardial infarction. The 90% stenosis in the distal rca was treated with placement of drug eluting stent. Post procedure, the residual stenosis was 0% with timi 3 flow.

 
Manufacturer Narrative

(b)(4).

 
Event Description

It was further reported that in (b)(6) 2016, the patient was diagnosed with silent myocardial ischemia and not silent myocardial infarction as previously reported.

 
Manufacturer Narrative

(b)(4).

 
Event Description

It was further reported that the study stent is not related to the event of silent myocardial ischemia.

 
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Brand NameSYNERGY¿
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6194752
MDR Text Key62992966
Report Number2134265-2016-12073
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
PMA/PMN NumberNA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/08/2016
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? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/16/2013
Device MODEL NumberH7493919928300
Device LOT Number15690418
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 Received04/17/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/06/2012
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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