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

Model Number	H7493926032220
Medical Device Problem Codes	Bent (1059); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.A 2.25 x 32 synergy ii drug eluting stent was selected to treat the lesion.During preparation, when the physician was loading the device onto a guide wire, it was noticed that the stent was mangled.The device was not used and the procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr, eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.A visual examination of the stent found the stent damaged with struts on the proximal side from row 4 to 16 bunched, overlapping and distorted exposing the balloon wall on the proximal side.The crimped stent od (outer diameter) at the undamaged portion was measured within specification.The product stent protector was not returned for analysis with the device.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.Crimp markings are evident on the exposed part of the balloon wall indicating crimp contact between the coated stent and balloon.The crimp temperature and the crimp duration for the device all are within the specified range.The bumper tip of the device showed no signs of damage.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 or Problem Description
It was reported that stent damage occurred.A 2.25 x 32 synergy ii drug eluting stent was selected to treat the lesion.During preparation, when the physician was loading the device onto a guide wire, it was noticed that the stent was mangled.The device was not used and the procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6157745
• Report Number: 2134265-2016-11660
• Device Sequence Number: 13807750
• Product Code: NIQ
• UDI-Device Identifier: 08714729840329
• UDI-Public: (01)08714729840329(17)20170707(10)19471962.
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2017
• Device Model Number: H7493926032220
• Device Catalogue Number: 39260-3222
• Device Lot Number: 19471962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2016
• Supplement Report FDA Received Date: 02/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1