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	H7493926008300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the left main (lm) extending to the left anterior descending (lad) artery.After laser and pre-dilation was performed, a 3.00 x 8 synergy ii drug-eluting stent was advanced to treat the lesion.However, the shaft near the hub broke.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: stent delivery system (sds) was returned for analysis without the manifold/hub, therefore the catheter batch/serial number cannot be identified.The stent was not returned for analysis.As part of the analysis, the stent profile manufacturing crimp data for the batch was reviewed and the maximum crimped stent outer diameter measurement for the whole batch at the time of manufacture was within the maximum crimped stent profile measurement which confirms that the complaint device stent profile was within specification.The balloon cones were reviewed and no issues were noted.Crimp stent markings were visible on the balloon body indicating that the stent was crimped on the balloon prior to stent detachment.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 on the distal edges of the tip.A visual and tactile examination found multiple kinks along several locations of the hypotube shaft.A hypo tube break at 1205mm from the distal tip edge was also noted during analysis.The manifold/hub and strain relief section of device was not returned for analysis.This type of damage is consistent with excessive pressure 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 shaft break occurred.The target lesion was located in the left main (lm) extending to the left anterior descending (lad) artery.After laser and pre-dilation was performed, a 3.00 x 8 synergy ii drug-eluting stent was advanced to treat the lesion.However, the shaft near the hub broke.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• 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: 6949036
• Report Number: 2134265-2017-10042
• Device Sequence Number: 1112016
• Product Code: NIQ
• UDI-Device Identifier: 08714729839996
• UDI-Public: 08714729839996
• 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): 09/26/2017

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: 03/30/2018
• Device Model Number: H7493926008300
• Device Catalogue Number: 39260-0830
• Device Lot Number: 20513434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Initial Date Received by Manufacturer: 09/26/2017
• Supplement Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 10/13/2017
• Supplement Report FDA Received Date: 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1