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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 H7493926028300
Device Problems Stent (515); Bent (1059); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Device is a combination product. (b)(4).

 
Event Description

It was reported that stent damage occurred. A 3. 00x28 synergy ii mr drug-eluting stent was selected for use. However, upon opening and removing the stent protector, it was noted that the stent strut was lifted. The stent did not enter the patient's body. The procedure was completed with a different device. There were no patient complications.

 
Manufacturer Narrative

Device evaluated by mfr: the stent delivery system (sds) was returned for analysis. A visual examination of the crimped stent found proximal stent damage with struts on the first two rows lifted distally from the stent profile. The remaining part of the stent showed no signs of damage. The crimped stent outer diameter (od) on the undamaged side was measured which the reading is within the specification. Based on the complaint report and the analysis performed, the damage noted most likely occurred due to mishandling during preparation. The balloon cones were reviewed and no issues were noted. The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure. The bumper tip of the device showed signs of damage to the distal edge of the tip. A visual and tactile examination found multiple kinks along the hypotube shaft. This type of damage is consistent with excessive force being applied to the delivery system. A visual and tactile examination of the outer and mid-shaft section found no issues. The inner lumen and bi-component bond showed no signs of damage or strain. No other issues were identified during the product analysis. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause is considered handling damage as the event occurred without direct patient contact. (b)(4).

 
Event Description

It was reported that stent damage occurred. A 3. 00x28 synergy ii mr drug-eluting stent was selected for use. However, upon opening and removing the stent protector, it was noted that the stent strut was lifted. The stent did not enter the patient's body. The procedure was completed with a different device. There were no patient complications.

 
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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 Key6191056
MDR Text Key62913289
Report Number2134265-2016-12079
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP150003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/08/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/20/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/06/2017
Device MODEL NumberH7493926028300
Device Catalogue Number39260-2830
Device LOT Number19454599
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/19/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/22/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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