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	H7493926008250
Medical Device Problem Codes	Bent (1059); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/04/2017
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 2.50 x 8 synergy ii drug eluting stent (des) was selected to treat the lesion.However, during preparation, the stent was damaged.The device was not used and the procedure was completed with another of the same device.No patient complications were reported.The patient's status was fine and was discharged in stable condition.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy ii us mr 2.50 x 8mm stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent found no issues.There were no signs of damage, lifting or stretching of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal markerbands.The crimped stent od (outer diameter) was measured which is within max crimped stent profile measurement.The balloon cones were reviewed and no issues were noted.A visual and tactile examination of the device found a break in the hypotube at approximately 437mm distal to the strain relief with multiple kinks along the catheter length.An examination of the shaft polymer extrusion found no issues.The bi-component bond showed no signs of damage.The tip was visually and microscopically examined and damage was noted.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 2.50 x 8 synergy ii drug eluting stent (des) was selected to treat the lesion.However during preparation, the stent was damaged.The device was not used and the procedure was completed with another of the same device.No patient complications were reported.The patient's status was fine and was discharged in stable condition.

• 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: 6516450
• Report Number: 2134265-2017-04009
• Device Sequence Number: 1594642
• Product Code: NIQ
• UDI-Device Identifier: 08714729839972
• UDI-Public: (01)08714729839972(17)20170926(10)19778702
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2017

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: 09/26/2017
• Device Model Number: H7493926008250
• Device Catalogue Number: 39260-0825
• Device Lot Number: 19778702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/05/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2017
• Supplement Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR