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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION SYNERGY XD CORONARY DRUG-ELUTING STENT Back to Search Results
Lot Number 0027337620
Device Problem Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2021
Event Type  malfunction  
Event Description
Reportable based on device analysis completed on 17dec2021. It was reported that crossing difficulties were encountered. The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery. The 20 x 3. 50 synergy stent was advanced directly for treatment but failed to cross the target lesion. The device was removed and the procedure completed with a different device. There were no patient complications. However, device analysis revealed stent damage.
 
Manufacturer Narrative
The synergy xd mr ous 3. 50 x 20mm stent delivery system was returned for analysis. A visual and microscopic examination of the stent found proximal stent damage, with stent struts lifted and pulled distally. The undamaged stent od (outer diameter) was measured 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 found distal tip damage. A visual and tactile examination of the hypotube found a hypotube kink located 20. 3cm distal to the distal strain relief. 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.
 
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Brand NameSYNERGY XD
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 Key13122110
MDR Text Key283152567
Report Number2134265-2021-16370
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial
Report Date 12/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number0027337620
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/04/2021
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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