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	H7493926012270
Medical Device Problem Codes	Stretched (1601); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.  device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.During preparation, a 2.75x12mm synergy ii stent was selected to treat the lesion.However, it was noted that stent struts were stretched to the tip of the balloon delivery system.The procedure was completed with another synergy stent.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent found that the stent was damaged and stretched in a distal direction over the tip.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.Stent crimp markings were visible on the balloon body indicating that the stent was crimped to the balloon prior to shipping.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the inner and outer lumen and mid-shaft section found no issues on the polymer extrusion.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.During preparation, a 2.75x12mm synergy ii stent was selected to treat the lesion.However, it was noted that stent struts were stretched to the tip of the balloon delivery system.The procedure was completed with another synergy stent.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: 6677989
• Report Number: 2134265-2017-06516
• Device Sequence Number: 72813
• Product Code: NIQ
• UDI-Device Identifier: 08714729840046
• UDI-Public: (01)08714729840046(17)20171021(10)19916071
• 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): 06/13/2017

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: 10/21/2017
• Device Model Number: H7493926012270
• Device Catalogue Number: 39260-1227
• Device Lot Number: 19916071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 07/04/2017
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 07/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1