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	H7493926012250
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2018-06647.It was reported that stent damage occurred.The target lesion was located in the calcified mid right coronary artery.A 2.50 x 16mm synergy ii drug-eluting stent was advanced but failed to cross the lesion and it was noted that the stent was damaged.The device was removed and a 2.50 x 12mm synergy ii drug-eluting stent was advanced but still failed to cross the lesion and damaged was also noted.The device was removed from the patient.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 2.50 x 12mm stent delivery system was returned for analysis.A visual examination of the crimped stent identified damage.Proximal strut 4 was lifted and bent in a proximal direction.The remainder of the stent was undamaged.The undamaged crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.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 and tactile examination of the device revealed multiple hypotube kinks.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 investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2018-06647.It was reported that stent damage occurred.The target lesion was located in the calcified mid right coronary artery.A 2.50 x 16mm synergy ii drug-eluting stent was advanced but failed to cross the lesion and it was noted that the stent was damaged.The device was removed and a 2.50 x 12mm synergy ii drug-eluting stent was advanced but still failed to cross the lesion and damaged was also noted.The device was removed from the patient.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: 7711884
• Report Number: 2134265-2018-06642
• Device Sequence Number: 2644279
• Product Code: NIQ
• UDI-Device Identifier: 08714729840039
• UDI-Public: 08714729840039
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/03/2018

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: 02/13/2019
• Device Model Number: H7493926012250
• Device Catalogue Number: 39260-1225
• Device Lot Number: 0021763446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1