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	H7493926012400
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Stent delivery system (sds) was returned for analysis.A visual examination of the stent found that the stent struts were damaged the whole stent length with the stent pushed proximally off the balloon and bunched down the polymer extrusion shaft, leaving the distal end of the stent located 2mm proximal of the proximal markerband.The damaged section of the crimped stent od (outer diameter) was measured.The stent profile at the time of manufacture was measured which was within the maximum crimped stent specification.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 examination of the bumper tip showed signs of damage along the distal edges of the tip.A visual and tactile examination found multiple kinks along several locations of the hypotube shaft.A visual and tactile examination of the outer and the inner lumen and mid-shaft section found no issues with the extrusion.The bi-component bond showed no signs of damage or strain.No other issues were identified during the product analysis.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on 25-oct-2017.It was reported that crossing difficulties were encountered.The target lesion was located in the circumflex artery.A 4.00 x 12mm synergy ii drug-eluting stent was advanced but failed to cross the lesion.No patient complications were reported.However, returned device analysis revealed stent moved on balloon and stent damage.

• 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: 7012442
• Report Number: 2134265-2017-11020
• Device Sequence Number: 156318
• Product Code: NIQ
• UDI-Device Identifier: 08714729840077
• UDI-Public: 08714729840077
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/25/2017

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: 09/20/2017
• Device Model Number: H7493926012400
• Device Catalogue Number: 39260-1240
• Device Lot Number: 19762553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1