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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 10617
Device Problem Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/14/2020
Event Type  Malfunction  
Manufacturer Narrative

Device evaluation by mfr. : a synergy ous mr 4. 00 x 12mm stent delivery system was returned for analysis. A visual examination of the stent found the stent damaged with the middle to distal region of the stent stretched and pulled over the distal tip, proximal struts lifted and pulled in a distal direction and stent moved distally on the balloon. Due to the stretching, the stent outer diameter could not be measured. No damage to the balloon was noted. Crimp stent markings were visible on the exposed balloon wall without any signs of positive pressure applied to balloon. The balloon wings were tightly wrapped and folded. A visual examination of the bumper tip showed no signs of damage. A visual and tactile examination of the hypotube found multiple kinks. 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 08 sep 2020. It was reported that crossing difficulty was encountered. The 95% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery. After the lesion was pre-dilated with a 20 x 15 non-bsc balloon catheter, a 4. 00 x 12 synergy drug-eluting stent was advanced for treatment but failed to cross the lesion. The procedure was completed with a different device. No patient complications nor injuries were reported. However, device analysis revealed stent damage and stent shifted/ moved.

 
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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 Key10608552
MDR Text Key209242629
Report Number2134265-2020-13553
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 09/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/19/2020
Device MODEL Number10617
Device Catalogue Number10617
Device LOT Number0023726381
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/11/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/23/2019
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: 09/30/2020 Patient Sequence Number: 1
Treatment
BALLOON CATHETER: 2.0X15 TREK
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