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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION SYNERGY CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 10619
Device Problem Fracture
Event Date 03/09/2020
Event Type  Malfunction  
Manufacturer Narrative

Device is a combination product. A synergy ous mr 2. 50 x 20 mm stent delivery system was returned for analysis. A visual examination of the stent found no issues. There was no sign of damage, stretching or lifting of the stent struts. The stent showed no signs of movement and was set between the proximal and distal markerbands. The crimped stent outer diameter was measured and the result was within maximum crimped stent profile measurement. The balloon cones were reviewed, and no issues were noted. The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure. A visual and microscopic examination of the bumper tip showed no signs of damage. A visual and tactile examination of the hypotube shaft found a break situated at 15. 5 cm distal to the distal end of strain relief as well as multiple kinks located immediately distal and proximal to the breaking site. A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion. No other issues were identified during the product analysis.

 
Event Description

Reportable based on device analysis completed on 28apr2020. It was reported that crossing difficulties were encountered. The patient had myocardal infarction <72 hours prior to procedure. The 80% stenosed, 2. 50x18mm, concentric, de novo target lesion with a significant bend of <=45 degrees was located in the mildy tortuous and severely calcified left anterior descending artery. Following predilatation with a 1. 50x15mm balloon, a 2. 50x20mm synergy ii des drug-eluting stent was advanced but failed to cross. It was also noted that the shaft broke during the procedure. The device was removed and the procedure completed with a different device. No patient complications were reported and the patient status was stable. However, device analysis revealed hypotube detached/separated.

 
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Brand NameSYNERGY
Type of DeviceCORONARY DRUG-ELUTING STENT
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 Key10089496
Report Number2134265-2020-07019
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 05/26/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/26/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number10619
Device Catalogue Number10619
Device LOT Number0024116401
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/30/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/08/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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