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 Codes	Bent (1059); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/20/2017
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 stent damage occurred.During preparation of a 2.25 x 24 synergy ii drug-eluting stent, it was noted that one of the stent struts was sticking out.The device never entered the patient's body and the procedure was completed without any issues.No patient complications were reported.
Additional Manufacturer Narrative
device evaluated by mfr: synergy ii us mr 2.25 x 24mm stent delivery system was returned for analysis.An examination of the crimped stent revealed damage.Proximal strut segment 1-2 were lifted and pulled distally.The remainder of the stent was undamaged.The undamaged section of the crimped stent od (outer diameter) 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 hypotube revealed multiple kinks.An examination of the shaft polymer extrusion found no issues.The bi-component bond showed no signs of damage or strain.The tip was visually examined and no issues were found.The product stent protector was not returned for analysis.Based on the specified inner diameter of the stent protector and the outer diameter of the stent, there are no issues to note with the interaction of the two components provided the stent protector was removed correctly.No other issues were identified during the product analysis.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.During preparation of a 2.25 x 24 synergy ii drug-eluting stent, it was noted that one of the stent struts was sticking out.The device never entered the patient's body and the procedure was completed without any issues.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: 6929089
• Report Number: 2134265-2017-09925
• Device Sequence Number: 116657
• Product Code: NIQ
• UDI-Device Identifier: 08714729840206
• UDI-Public: 08714729840206
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2017

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: 11/02/2017
• Device Model Number: H7493926024220
• Device Catalogue Number: 39260-2422
• Device Lot Number: 19933499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Initial Date Received by Manufacturer: 09/22/2017
• Supplement Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 10/09/2017
• Supplement Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1