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	H7493926016270
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.A 2.75x16mm synergy ii everolimus-eluting platinum chromium coronary stent system was selected to treat the lesion.However, during preparation, as the physician was pulling the stent protector off to the distal end, the shaft broke into two.The procedure was completed with a different device.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Stent delivery system was returned for analysis.A visual examination of the stent found no issues.There was no sign 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 outer diameter was measured and is 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 microscopic examination of the bumper tip showed damage.A visual and tactile examination of the hypotube found multiple hypotube kinks along the full length of the catheter.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the shaft polymer extrusion found a break at the port weld site and multiple inner/outer polymer extrusion kinks along the full length of the shaft polymer extrusion.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
It was reported that shaft break occurred.A 2.75x16mm synergy ii everolimus-eluting platinum chromium coronary stent system was selected to treat the lesion.However, during preparation, as the physician was pulling the stent protector off to the distal end, the shaft broke into two.The procedure was completed with a different device.No patient complications were reported and the patient's status was fine.

• 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: 6601011
• Report Number: 2134265-2017-05337
• Device Sequence Number: 19029736
• Product Code: NIQ
• UDI-Device Identifier: 08714729840107
• UDI-Public: (01)08714729840107(17)20170907(10)19719505
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/11/2017

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: 09/07/2017
• Device Model Number: H7493926016270
• Device Catalogue Number: 39260-1627
• Device Lot Number: 19719505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/31/2017
• Supplement Report FDA Received Date: 06/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1