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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 H7493926220250
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Cardiogenic Shock (2262)
Event Date 09/21/2017
Event Type  Death  
Manufacturer Narrative
(b)(4). Catalog mode# updated. (b)(4).
 
Event Description
Same case as mdr#2134265-2017-09964. It was reported that loss of blood pressure, cardiogenic shock, and death occurred. The patient presented with almost no-flow in the right coronary artery (rca). In the physician¿s opinion the patient¿s vessel condition was bad and the patient could not undergo surgery. The 95-99% stenosed target lesion was located in the left anterior descending artery (lad). During the first pre-dilatation with an nc emerge balloon the patient's blood pressure suddenly dropped. The patient was given vasopressors and a 2. 5x20mm synergy stent was implanted in the left main over the lad in an attempt to increase the blood flow. The patient's blood pressure did not improve and cardiopulmonary resuscitation was performed for an hour. The patient went into cardiogenic shock and died.
 
Manufacturer Narrative
Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed. (b)(4).
 
Event Description
Same case as mdr#2134265-2017-09964. It was reported that loss of blood pressure, cardiogenic shock, and death occurred. The patient presented with almost no-flow in the right coronary artery (rca). In the physician¿s opinion the patient¿s vessel condition was bad and the patient could not undergo surgery. The 95-99% stenosed target lesion was located in the left anterior descending artery (lad). During the first pre-dilatation with an nc emerge balloon the patient's blood pressure suddenly dropped. The patient was given vasopressors and a 2. 5x20mm synergy stent was implanted in the left main over the lad in an attempt to increase the blood flow. The patient's blood pressure did not improve and cardiopulmonary resuscitation was performed for an hour. The patient went into cardiogenic shock and died.
 
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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 Key6912621
MDR Text Key105944204
Report Number2134265-2017-10152
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
SIMILAR
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 09/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberH7493926220250
Device Catalogue Number39262-2025
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 Received09/22/2017
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

Patient Treatment Data
Date Received: 10/03/2017 Patient Sequence Number: 1
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