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	H7493926032400
Medical Device Problem Codes	Bent (1059); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/17/2017
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 4.00x32mm synergy ii everolimus-eluting platinum chromium coronary stent system was selected to treat the lesion.However, during unpacking, the physician noticed that a stent strut was "flared up".The device never went into the patient's body.The procedure was completed with another synergy stent.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy ii us mr 4.00 x 32mm stent delivery system (sds) was returned for analysis.An examination of the crimped stent identified proximal stent damage.Stent strut rows 1-8 from the proximal end of the stent were damaged and deformed.The remainder of the struts were undamaged.The crimped stent outer diameter of the undamaged section was measured and the result was within maximum crimped stent profile measurement.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.A visual and tactile examination of the hypotube found multiple kinks along the full catheter length.An examination of the shaft polymer extrusion found no issues.The bi-component bond showed no signs of damage or strain.The tip was visually examined and no issues were found.The product stent protector was not returned for analysis with the device.The product stent protector was not returned for analysis with the device, however, based on the specified stent protector profile and the stent outer diameter (od) for this device, there is no issues to note with the interaction between the two components.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 4.00x32mm synergy ii everolimus-eluting platinum chromium coronary stent system was selected to treat the lesion.However, during unpacking, the physician noticed that a stent strut was "flared up".The device never went into the patient's body.The procedure was completed with another synergy stent.No patient complications were reported and the patient's status was fine.

• 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: 6552501
• Report Number: 2134265-2017-04496
• Device Sequence Number: 11035056
• Product Code: NIQ
• UDI-Device Identifier: 08714729840374
• UDI-Public: (01)08714729840374(17)20170818(10)19633227
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2017

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: 08/18/2017
• Device Model Number: H7493926032400
• Device Catalogue Number: 39260-3240
• Device Lot Number: 19633227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/19/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2017
• Supplement Report FDA Received Date: 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1