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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC CORPORATION SYNERGY CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Device Problem Material Deformation (2976)
Patient Problem Death (1802)
Event Date 12/01/2019
Event Type  Death  
Manufacturer Narrative
Date of event: the date of the event is unknown. Bsc became aware of the reported event on 10 december 2019. Therefore, a date of 01 december was entered to indicate that the event occurred on an unknown day in (b)(6) 2019.
 
Event Description
It was reported that stent damage and a patient death occurred. The target lesion was located in a heavily calcified right coronary artery (rca). While attempting to deliver a 3. 00 x 48mm synergy stent to the target lesion, it crumbled. The stent was not inflated and the device was removed. Using a guidezilla, another of the same sized stent was delivered to the target lesion. The procedure was completed without any further complications. However, six hours post the procedure, the patient died. It was noted that the patient death was not related to the stent or the procedure.
 
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Brand NameSYNERGY
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9495080
MDR Text Key172000561
Report Number2134265-2019-15969
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUK
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 12/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received12/10/2019
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: 12/19/2019 Patient Sequence Number: 1
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