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 Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that foreign matter was present on the shaft.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified obtuse marginal circumflex artery.When a 2.25 x 24 synergy ii drug-eluting stent was advanced, it was noted that there was a foreign matter on the shaft which could not be removed.The product was completely removed from the patient and the procedure was completed with another of the same device.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.A visual examination of the crimped stent revealed no issues.There were no signs of damage or lifting of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal markerbands.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 and were not subjected to positive pressure.A visual and tactile examination of the hypotube was performed and there were no signs of kinks or damage to the hypotube.An examination of the shaft polymer extrusion revealed no issues.There were no signs of damage to the inner or outer shaft polymer extrusion.The bi-component bond showed no signs of damage or strain.The tip was visually and microscopically examined and no issues were noted.Foreign matter (fm) noted on hypotube.A tactile inspection of the fm was consistent with a plastic material.It could be moved freely in a proximal and distal direction on the hypotube section.The fm could also move distally towards the midshaft/hypotube bond and port weld section, however it felt slightly tighter to move due to the extrusion layer on device.There was no damage to the midshaft/hypotube bond, port weld or proximal weld sections of the device.No trace of fm around the bond sites noted.All welds were visually normal.Foreign matter was returned separate to the device and was sent for characterization using fourier transform infra-red spectroscopy (ftir).A library search of the fm was performed and it produced a match of over 99% with the heatshrink reference sample.No other issues were identified during the product analysis.The investigation conclusion is manufacturing execution error as the manufacturing process was not executed as validated/as designed.(b)(4).
Event or Problem Description
It was reported that foreign matter was present on the shaft.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified obtuse marginal circumflex artery.When a 2.25 x 24 synergy ii drug-eluting stent was advanced, it was noted that there was a foreign matter on the shaft which could not be removed.The product was completely removed from the patient and the procedure was completed with another of the same device.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: 7126410
• Report Number: 2134265-2017-12486
• Device Sequence Number: 1210723
• Product Code: NIQ
• UDI-Device Identifier: 08714729840206
• UDI-Public: 08714729840206
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/03/2018
• Device Model Number: H7493926024220
• Device Catalogue Number: 39260-2422
• Device Lot Number: 0020855946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR