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	H7493926024250
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2018
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 a coronary vessel.A 2.50 x 24 synergy ii stent was advanced to treat the lesion.However, upon advancing the device, it was noticed under fluoroscopy that the stent did not look right.The device was removed and it was noted that the stent struts were damaged.The procedure was completed with a different device.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: stent delivery system was returned for analysis.A visual examination of the stent found that stent struts from the proximal to the mid-section of the stent were damaged, stent struts were stretched, pushed and bunched in a distal direction around the mid-section of the stent.The undamaged distal section of the crimped stent outer diameter was measured and the result was within maximum crimped stent profile measurement.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded on the distal balloon cones and were not subjected to positive pressure.Stent crimp markings were present on the exposed proximal balloon body.The tip was visually and microscopically examined and no signs of damage were noted.A visual and tactile examination of the hypotube found multiple kinks along several locations of the hypotube shaft.This type of damage is consistent with excessive force being applied on the delivery system.A visual and tactile examination of the outer and the inner lumen and mid-shaft section found no issues with the extrusion shaft.The bi-component bond showed no signs of damage or strain.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
It was reported that stent damage occurred.The target lesion was located in a coronary vessel.A 2.50 x 24 synergy ii stent was advanced to treat the lesion.However, upon advancing the device, it was noticed under fluoroscopy that the stent did not look right.The device was removed and it was noted that the stent struts were damaged.The procedure was completed with a different device.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: 7567603
• Report Number: 2134265-2018-04954
• Device Sequence Number: 14110769
• Product Code: NIQ
• UDI-Device Identifier: 08714729840213
• UDI-Public: 08714729840213
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 05/14/2018

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: 01/31/2019
• Device Model Number: H7493926024250
• Device Catalogue Number: 39260-2425
• Device Lot Number: 0021717754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 06/04/2018
• Supplement Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1