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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
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BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Model Number 10607
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 11/30/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that shaft break occurred and patient was sent for surgery.The 90% stenosed target lesion was located in the severely tortuous and severely calcified circumflex.A 2.75 x 38 synergy ii drug-eluting stent was implanted.However, when removing the catheter, it would not pull out from the lesion and it was noted that the shaft broke at the junction between the mid and distal shaft.The balloon end was left in the patient's body and the patient was sent for emergency sternotomy to remove the broken parts.It was successfully retrieved from the patient's body and the patient was stable post procedure.
 
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Brand Name
SYNERGY
Common Device Name
BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11004158
Report Number2134265-2020-17579
Device Sequence Number16361106
Product Code NIQ
UDI-Device Identifier08714729840404
UDI-Public08714729840404
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
P150003
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date02/17/2022
Device Model Number10607
Device Catalogue Number10607
Device Lot Number0025326600
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/01/2020
Initial Report FDA Received Date12/14/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age56 YR
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