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	H7493926024270
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr: synergy ii us mr 2.75 x 24mm stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent identified slight damage.Stent strut row 1 from the proximal end was moved in a proximal direction over the proximal markerband.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 device revealed multiple hypotube kinks.An examination of the shaft polymer extrusion revealed a bunch in the inner shaft polymer extrusion at approximately 30mm proximal to the proximal markerband.It was not possible to insert a 0.014" guidewire due to the damage noted to the inner shaft polymer extrusion.The tip was visually and microscopically examined and no issues were 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 considered handling damage as the event occurred without direct patient contact.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on 26-apr-2017.It was reported that insertion difficulties were encountered. during introduction of a 2.75 x 24 synergy ii drug-eluting stent into a pt graphix guide wire, the device was unable to feed over the guide wire.The device never entered the patient's body and the procedure was completed with another 2.75 x 24 synergy ii drug-eluting stent and the same pt graphix guide wire.No patient complications were reported.However, returned device analysis revealed stent damage.

• 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: 6556837
• Report Number: 2134265-2017-04607
• Device Sequence Number: 19004583
• Product Code: NIQ
• UDI-Device Identifier: 08714729840220
• UDI-Public: (01)08714729840220(17)20171219(10)20128637
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Report Date (Section B): 04/26/2017

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: 12/19/2017
• Device Model Number: H7493926024270
• Device Catalogue Number: 39260-2427
• Device Lot Number: 20128637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2017
• Initial Report FDA Received Date: 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PT GRAPHIX GUIDE WIRE