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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 H7493941832300
Device Problems Material Rupture (1546); Defective Device (2588); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)
Patient Problems Pain (1994); Vasoconstriction (2126); Discomfort (2330)
Event Date 03/02/2022
Event Type  Injury  
Event Description
It was reported that stent dislodgement occurred and the patient experienced vasospasms and pain. The 80% stenosed target lesion was located in the non-tortuous and mildly calcified mid left anterior descending artery. A 3. 00 x 32mm synergy xd drug-eluting stent was advanced for treatment. The stent was delivered in the normal manner with no issues. When the physician started to dial pressure on the indeflator and got to 11-12 atmospheres, no contrast could be seen on fluoroscopy. The physician pulled negative and tried to re-inflate but was unsuccessful and it was noticed that there was blood in the indeflator. It was unknown if the balloon had ruptured or if there was a hole in the shaft. The device was pulled back out of the coronary artery and halfway into another manufacturers 6fr ebu 3. 75 guide catheter. Afterwards the guide catheter, guidewire and the stent were pulled back into the radial artery. However, the stent came off the balloon and had to be snared and removed from the radial artery through the radial sheath. At this time that patient experienced radial artery vascospasms and pain in their right arm. The physician was unable to completely retrieve the device. The stent became foreshortened and compressed into a small ball of metal. Everything was removed from the patients right radial artery. A transradial band was applied and hemostasis was achieved. The patient experienced considerable pain and discomfort upon removal of the device from the radial artery. A follow-up angiogram was done from the right subclavian artery all the way down to the wrist to make sure there was no perforation or dissections present. The procedure was completed with a 3. 00mm x 38mm synergy xd drug-eluting stent. No further patient complications were reported and the patient has fully recovered.
 
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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 Key13802944
MDR Text Key288092741
Report Number2134265-2022-02665
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH7493941832300
Device Lot Number0028036541
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/07/2021
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: 03/17/2022 Patient Sequence Number: 1
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