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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

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BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Model Number H7493926020350
Device Problems Bent (1059); Migration or Expulsion of Device (1395); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2017
Event Type  Injury  
Manufacturer Narrative
Device is a combination product. (b)(4). Device evaluated by mfr: the device was not received for analysis. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).
 
Event Description
It was reported that balloon removal difficulties were encountered, stent migration and stent damaged occurred. The target lesion was located in the left anterior descending (lad) artery. A 3. 50 x 20mm synergy ii drug-eluting stent was deployed. Following post dilation, the balloon was deflated but could not be removed from the stent. The stent then moved into the left main (lm) artery and was elongated approximately 21. 5mm per intravascular ultrasound. The stent in lm was post dilated with a 4. 5x8 non-bsc balloon catheter and lad was dilated with a 4. 0x15 non-bsc balloon catheter without stenting. The procedure was then completed. No patient complications were reported and the patient was doing well.
 
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Brand NameSYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Type of DeviceBIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7151055
MDR Text Key95929258
Report Number2134265-2017-12834
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729840183
UDI-Public08714729840183
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P150003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/14/2018
Device Model NumberH7493926020350
Device Catalogue Number39260-2035
Device Lot Number0021043056
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2017
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: 12/28/2017 Patient Sequence Number: 1
Treatment
BALLOON CATHETER: NC TREK 4.0X15MM; BALLOON CATHETER: NC TREK 4.5X8MM
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