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	H7493926008350
Medical Device Problem Codes	Bent (1059); Device Damaged Prior to Use (2284); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that stent dislodgement and stent damage occurred.A 3.50 x 8 synergy ii drug eluting stent (des) was selected to treat the lesion.However during preparation, it was noted that the stent was not on the balloon but was found on the stylet after the stylet had been removed from the catheter.It was also noticed that the stent looked elongated and wrapped up.The device was not used and the procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the stent delivery system (sds) was not returned for analysis therefore the catheter batch/serial number cannot be identified.The stent was not returned for analysis.A review of the synergy manufacturing data for the finished goods batch was performed and no anomalies were noted during the production of this batch.A stent protector inner diameter that was returned for analysis was measured and is within specification.The sds was not returned for analysis therefore reviews for individual assessment of the catheter could not be performed.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 dislodgement and stent damage occurred.A 3.50 x 8 synergy ii drug eluting stent (des) was selected to treat the lesion.However, during preparation, it was noted that the stent was not on the balloon but was found on the stylet after the stylet had been removed from the catheter.It was also noticed that the stent looked elongated and wrapped up.The device was not used and the procedure was completed with a different 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: 6345339
• Report Number: 2134265-2017-01261
• Device Sequence Number: 16314229
• Product Code: NIQ
• UDI-Device Identifier: 08714729840008
• UDI-Public: (01)08714729840008(17)20171010(10)19848930
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/01/2017

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: 10/10/2017
• Device Model Number: H7493926008350
• Device Catalogue Number: 39260-0835
• Device Lot Number: 19848930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/01/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2017
• Supplement Report FDA Received Date: 03/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1