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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 10619
Device Problems Deflation Problem (1149); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2021
Event Type  malfunction  
Event Description
It was reported that difficulty removing a balloon occurred. A percutaneous coronary intervention (pci) was performed on an 80% stenosed lesion located in the mildly calcified left main (lm) artery. Following predilatation, a 4. 50 x 20 synergy stent was advanced. The stent delivery balloon was inflated to 16 atmospheres for 20 seconds. The 4. 50 x 20 synergy stent was deployed in the lm. The stent delivery balloon was deflated and 40 seconds was waited to retrieve the balloon. There were difficulties removing the stent delivery balloon. The stent delivery balloon was stuck to 4. 50 x 20 synergy stent. The stent delivery balloon was then inflated to 18 atmospheres. There was still difficulty retrieving the stent delivery balloon. Force was used to remove the stent delivery balloon. It was noted that stent delivery balloon was still partially inflated and intact at the time of removal. There was no physical damage noticed to the synergy stent delivery system. The procedure was completed. There was no patient complications reported in relation to this event.
 
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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 Key12513552
MDR Text Key272724049
Report Number2134265-2021-11948
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 11/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/19/2022
Device Model Number10619
Device Catalogue Number10619
Device Lot Number0025281122
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2020
Is the Device Single Use? Yes
Type of Device Usage Initial

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