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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - GALWAY SYNERGY¿ CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number H7493919928220
Device Problem Occlusion Within Device (1423)
Patient Problems Myocardial Contusion (1763); Chest Pain (1776); Nausea (1970); Reocclusion (1985); Dizziness (2194)
Event Date 07/12/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was further reported that in (b)(6) 2017, the patient presented emergently with sudden onset of substernal chest pain radiating to left arm and jaw accompanied by nausea and dizziness. The patient was hospitalized on the same day. At the time of event, therapy with clopidogrel was exchanged to ticagrelor and aspirin was continued. The patient was not on statin therapy. The patient was diagnosed with inferior stemi with complete resolution of st elevation after 45 minutes. The 70% in-stent restenosis was treated with placement of a 3. 25x38mm non-bsc stent with 0% residual stenosis and timi 3 flow.
 
Manufacturer Narrative
Device is a combination product. 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 myocardial infarction (mi) and in-stent restenosis (isr) occurred. In (b)(6) 2013, clinical status assessment identified that the patient's qualifying condition as unstable angina. Subsequently, the index procedure was performed. Target lesion # 1 was located in the mid right coronary artery (rca) with 90% stenosis, a length of 20 mm, and a reference vessel diameter of 2. 25 mm. Target lesion # 1 was treated with pre-dilatation, placement of a 2. 25 x 28 mm study stent and post-dilatation with 0% residual stenosis. Target lesion # 2 was located in the distal left circumflex(lcx) artery with 70% stenosis, a length of 15 mm, and a reference vessel diameter of 3. 00 mm. Target lesion # 2 was treated with pre-dilatation, and placement of a 3. 00 x 20 mm study stent following which the residual stenosis was 0%. The following day, the patient was discharged on dual antiplatelet therapy. In (b)(6) 2017, the patient was admitted to the hospital and was diagnosed with st-elevation myocardial infarction (stemi). Cardiac catheterization was recommended which revealed in-stent restenosis of study stent placed in the mid rca and was treated with percutaneous coronary intervention (pci). The patient was also given tenecteplase (tnk) therapy in response to this event. Two days after the event was considered resolved and the patient was discharged.
 
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Brand NameSYNERGY¿
Type of DeviceCORONARY DRUG-ELUTING STENT
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 Key6744065
MDR Text Key107135939
Report Number2134265-2017-07867
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/14/2013
Device Model NumberH7493919928220
Device Lot Number15684326
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 Received07/31/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2012
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: 07/26/2017 Patient Sequence Number: 1
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