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	H7493926112400
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that a foreign matter was present in the device.During preparation of a 4.00 x 12 synergy ii stent, it was noted that there was a blue kind of fuzzy material on the stent.The device was replaced and the procedure was completed with another 4.00 x 12 synergy ii stent.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr.: synergy ii us otw 4.00 x 12mm stent delivery system was returned for analysis.Prior to decontamination the device was visually inspected.A visual and microscopic examination of the crimped stent found piece of blue fibre like foreign matter (fm) on the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.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 found no issues.A visual and microscopic examination found no damage to the tip.The fm was removed from the stent, the fm was easily removed it was not caught in the stent.The fm was placed in a beaker for material characterization analysis in the material characterization lab.The fm appeared to be a number of fibres with a total length of approximately 8 mm.The fm was sectioned in two, with one section imaged using scanning electron microscopy (sem) and the other assessed with fourier transform jnfrared spectroscopy (ftir).The sem images showed that the fibres had a distinctive twist feature throughout their length.The ftir produced a spectrum consistent with that of a cellulose based material.The library search produced a match of over 87% with a cotton fibre.The combination of the twisting structure of the fibres and the ftir spectra suggest that the fm is bundle of cotton fibres.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 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 a foreign matter was present in the device.During preparation of a 4.00 x 12 synergy ii stent, it was noted that there was a blue kind of fuzzy material on the stent.The device was replaced and the procedure was completed with another 4.00 x 12 synergy ii stent.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: 7429950
• Report Number: 2134265-2018-03055
• Device Sequence Number: 1718875
• Product Code: NIQ
• UDI-Device Identifier: 08714729840558
• UDI-Public: 08714729840558
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/22/2018

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: 12/05/2018
• Device Model Number: H7493926112400
• Device Catalogue Number: 39261-1240
• Device Lot Number: 21501154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1