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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
Model Number H7493941820350
Device Problem Material Deformation (2976)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/22/2020
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.A 3.50 x 20mm synergy xd drug-eluting stent (des) was advanced for treatment.However, the stent was damaged while pulling back into the guide.The procedure was completed with another synergy xd des.No known patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: a synergy xd mr us 3.50 x 20mm stent delivery system was returned for analysis with a haemostatic valve attached.Examination of the crimped stent via scope found evidence of damage with proximal struts lifted and pulled distally.The undamaged crimped stent outer diameter was measured and the result is within max crimped stent profile measurement.The balloon cones were reviewed via scope, and no issues were noted.The balloon wings were tightly wrapped and evenly folded.The balloon had not been subjected to positive pressure.A visual and tactile examination of the hypotube identified multiple kinks along the length of the hypotube shaft.Examination of the tip via scope found no damage to the tip.The shaft polymer extrusion including the distal and mid-shaft sections were examined via scope and tactile examination.No issues were noted.Examination of the hub and strain relief via scope did not identify any issues.No other issues were identified during the product analysis.
 
Event Description
It was reported that stent damage occurred.A 3.50 x 20mm synergy xd drug-eluting stent (des) was advanced for treatment.However, the stent was damaged while pulling back into the guide.The procedure was completed with another synergy xd des.No known patient complications were reported.It was further reported that the target lesion was not tortuous but mildly calcified by fluoroscopy.
 
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Brand Name
SYNERGY XD
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11094247
MDR Text Key224398102
Report Number2134265-2020-18576
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729981053
UDI-Public08714729981053
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/14/2022
Device Model NumberH7493941820350
Device Lot Number0026088524
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2021
Date Manufacturer Received02/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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