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	H7493926024220
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the distal circumflex artery.A 2.25 x 24 synergy ii drug-eluting stent was advanced but failed to cross the lesion.The device was removed and a stent strut on the proximal portion of the stent was noted to be lifted.Subsequently, a 2.25 x 28 synergy drug-eluting stent was implanted in the distal circumflex artery and another 2.50 x 28 synergy drug-eluting stent was implanted in the mid circumflex artery, and the procedure was completed.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.:synergy ii us mr 2.25 x 24mm stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent found proximal damage.Stent strut rows 4 and 5 from the proximal end of the stent were lifted and pulled distally.The crimped stent od (outer diameter) of the undamaged portion was measured and 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 found multiple kinks along the full catheter length.An examination of the shaft polymer extrusion revealed a kink in the mid shaft at approximately 3.5cm distal of the hypotube/mid shaft bond.The bi-component bond showed no signs of damage.The tip was visually and microscopically examined and slight 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 most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the distal circumflex artery.A 2.25 x 24 synergy ii drug-eluting stent was advanced but failed to cross the lesion.The device was removed and a stent strut on the proximal portion of the stent was noted to be lifted.Subsequently, a 2.25 x 28 synergy drug-eluting stent was implanted in the distal circumflex artery and another 2.50 x 28 synergy drug-eluting stent was implanted in the mid circumflex artery, and the procedure was completed.No patient complications were reported and the patient's status was 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: 6619983
• Report Number: 2134265-2017-05874
• Device Sequence Number: 10766082
• Product Code: NIQ
• UDI-Device Identifier: 08714729840206
• UDI-Public: (01)08714729840206(17)20170829(10)19674494
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/24/2017

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: 08/29/2017
• Device Model Number: H7493926024220
• Device Catalogue Number: 39260-2422
• Device Lot Number: 19674494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2017
• Supplement Report FDA Received Date: 06/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR