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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
Device Problems Positioning Failure (1158); Positioning Problem (3009)
Patient Problem Pain (1994)
Event Date 11/28/2023
Event Type  Injury  
Event Description
It was reported that stent placement failed and the patient experienced pain.Two synergy xd were advanced for treatment, but failed to "hook" and had to be pulled out.Per the patient, inadequate sedation was provided and excruciating pain during removal of the stents was experienced.A third synergy xd was successfully placed to complete the procedure.
 
Manufacturer Narrative
Correction: h6 device code.
 
Event Description
It was reported that stent placement failed and the patient experienced pain.Two synergy xd were advanced for treatment, but failed to "hook" and had to be pulled out.Per the patient, inadequate sedation was provided and excruciating pain during removal of the stents was experienced.A third synergy xd was successfully placed to complete the procedure.
 
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Brand Name
SYNERGY XD
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18499299
MDR Text Key332708261
Report Number2124215-2024-01387
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/06/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received01/31/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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