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	H7493926032250
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/14/2018
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 found stuck on the stent.A 2.50 x 32 synergy ii drug-eluting stent was selected for use.However, when the physician attempted to load product onto wire, it was noted that there was something wrong with the stent.It felt like the stent was caught with some fiber/gauze.The device was never used inside the patient.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the stent delivery system was returned for analysis.A visual examination of the stent found no issues 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 equidistant between the proximal and distal markerbands.The crimped stent od (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 on the distal balloon cones and were not subjected to positive pressure.A visual examination of the bumper tip showed no signs of damage.A visual and tactile examination found multiple hypotube kinks along several locations of the hypotube shaft.This type of damage is consistent with excessive force being applied on the delivery system.A visual and tactile examination of the outer and the inner lumen and mid-shaft section found no issues with the extrusion shaft.As part of analysis, the device was loaded on a recommended 0.014'' guidewire without resistance or issue.The 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 investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).
Event or Problem Description
It was reported that foreign matter was found stuck on the stent.A 2.50 x 32 synergy ii drug-eluting stent was selected for use.However, when the physician attempted to load product onto wire, it was noted that there was something wrong with the stent.It felt like the stent was caught with some fiber/gauze.The device was never used inside the patient.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: 7578475
• Report Number: 2134265-2018-05048
• Device Sequence Number: 1523859
• Product Code: NIQ
• UDI-Device Identifier: 08714729840336
• UDI-Public: 08714729840336
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/14/2018

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: 09/26/2018
• Device Model Number: H7493926032250
• Device Catalogue Number: 39260-3225
• Device Lot Number: 0021212141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 06/17/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1