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	H7493926032270
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr: 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 stent damage occurred.A 2.75 x 32 synergy ii drug-eluting stent was advanced for treatment.However, during insertion, the stent strut was noted to be malformed.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.The following day, the patient was discharged.
Additional Manufacturer Narrative
Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent found the stent damaged with struts from the 11th most proximal row onwards distorted, lifted from the stent profile and stretched distally over the bumper tip.The crimped stent outer diameter (od) on the undamaged proximal side was measured and is within the specification.The balloon cones and main body were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.The bumper tip of the device showed no signs of damage.A visual and tactile examination found multiple kinks along the hypotube shaft.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the outer and mid-shaft section found no issues.The inner lumen and 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 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.A 2.75 x 32 synergy ii drug-eluting stent was advanced for treatment.However, during insertion, the stent strut was noted to be malformed.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.The following day, the patient was discharged.

• 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: 6182491
• Report Number: 2134265-2016-11967
• Device Sequence Number: 937582
• Product Code: NIQ
• UDI-Device Identifier: 08714729840343
• UDI-Public: (01)08714729840343(17)20170811(10)19617987
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2016

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: 08/11/2017
• Device Model Number: H7493926032270
• Device Catalogue Number: 39260-3227
• Device Lot Number: 19617987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2016
• Supplement Report FDA Received Date: 02/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1