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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 H7493926038350
Device Problems Detachment Of Device Component (1104); Material Rupture (1546)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/07/2018
Event Type  Injury  
Manufacturer Narrative
Age at time of event: 18 years or older.Device is a combination product.(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
 
Event Description
It was reported balloon rupture and detachment occurred.The patient presented with acute myocardial infarction.The target lesion was located in the right coronary artery (rca) with thrombus.It was tortuous in the distal portion.A non-bsc guide extension catheter was placed.Two 3.50x38mm synergy ii drug-eluting stents were deployed in the rca.After deploying one of the stents, post-dilation was performed with the stent balloon and it ruptured, detached and "shredded".The patient did not undergo surgery.No patient complications were reported.The patient¿s status was well.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned with the distal section missing (the stent, balloon and tip as well as the mid-shaft, inner/outer extrusion shafts.) a visual and tactile examination found a hypotube break at 29mm distal from the hypotube/mid-shaft bond.Multiple hypotube kinks were also noted during device examination.The type of damages noted most likely occurred due to excessive forces that could have been applied on the delivery system.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 balloon rupture and detachment occurred.The patient presented with acute myocardial infarction.The target lesion was located in the right coronary artery (rca) with thrombus.It was tortuous in the distal portion.A non-bsc guide extension catheter was placed.Two 3.50x38mm synergy ii drug-eluting stents were deployed in the rca.After deploying one of the stents, post-dilation was performed with the stent balloon and it ruptured, detached and "shredded".The patient did not undergo surgery.No patient complications were reported.The patient¿s status was well.
 
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Brand Name
SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Type of Device
BIODEGRADABLE 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 Key7232693
MDR Text Key98730678
Report Number2134265-2018-00352
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729840428
UDI-Public08714729840428
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 Physician
Type of Report Initial,Followup
Report Date 01/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/08/2018
Device Model NumberH7493926038350
Device Catalogue Number39260-3835
Device Lot Number0021379956
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/08/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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