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	H7493926032250
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
Same case as mdr id 2134265-2017-01849 and 2134265-2017-01851.It was reported that stent damage occurred.The target lesion was chronically totally occluded (cto).A 2.50 x 24, 2.50 x 32 and 2.50 x 38 synergy ii stent were advanced through a non-bsc guide extension catheter and then failed to cross the lesion.The stents were damaged while pulling back into the guide extension catheter for removal.The procedure was completed with a different device.There were no patient complications and the patient's status is fine.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy ii us mr 2.50 x 32mm stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the crimped stent found stent damage.Distal and central stent struts were damaged.Distal stent struts were stretched distally to the device tip.The undamaged proximal section of the crimped stent od (outer diameter) was measured and is within maximum crimped stent profile measurement.The balloon was reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Crimp markings were evident on the balloon wall exposed beneath the stretch stent, indicating correct positioning and crimping of the stent prior to the complaint incident.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of the shaft polymer extrusion revealed no issues.A visual and microscopic examination found damage to the tip.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 has been determined to be use/user error as the dfu states: ¿the safety and effectiveness of the synergy stent have not been established in the cerebral, carotid, or peripheral vasculature or in the following patient populations: patients with a chronic total occlusion.¿¿, however as per the complaint report a chronic total occlusion (cto) procedure was being carried out.Also the dfu states: ¿if unusual resistance is felt at any time during lesion access before stent implantation, the stent delivery system and the guide catheter should be removed as a single unit.Do not attempt to pull an unexpanded stent back into the guide catheter, as stent or coating damage or stent dislodgment from the balloon may occur.'', however as per the complaint report the stents were damaged while pulling back into the guide extension catheter for removal.(b)(4).
Event or Problem Description
Same case as mdr id 2134265-2017-01849 and 2134265-2017-01851.It was reported that stent damage occurred.The target lesion was chronically totally occluded (cto).A 2.50 x 24, 2.50 x 32 and 2.50 x 38 synergy ii stent were advanced through a non-bsc guide extension catheter and then failed to cross the lesion.The stents were damaged while pulling back into the guide extension catheter for removal.The procedure was completed with a different device.There were no patient complications and the patient's status is 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: 6390999
• Report Number: 2134265-2017-01850
• Device Sequence Number: 67346
• Product Code: NIQ
• UDI-Device Identifier: 08714729840336
• UDI-Public: (01)08714729840336(17)20170811(10)19611603
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 02/16/2017

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: 08/11/2017
• Device Model Number: H7493926032250
• Device Catalogue Number: 39260-3225
• Device Lot Number: 19611603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2017
• Supplement Report FDA Received Date: 04/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE EXTENSION CATHETER: GUIDELINER