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	H7493926012270
Medical Device Problem Codes	Bent (1059); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.A 2.75x12mm synergy ii drug eluting stent was selected for use.However, during unpacking, it was noted that the proximal end of the stent struts were peeled back.The procedure was completed with another stent.No patient complications were reported and patient's status is okay.
Additional Manufacturer Narrative
Device evaluated by mfr.: the stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent found that proximal stent row 1 was damaged and stent struts were lifted and pulled distally.Proximal stent rows 2-6 were deformed.The maximum crimped stent profile measurement at the time of manufacture was reviewed and was within maximum crimped stent profile measurement.The tip was visually and microscopically examined and damage was noted.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 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 slight polymer extrusion kink 17mm distal from the distal edge of device tip.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 stent damage occurred.A 2.75x12mm synergy ii drug eluting stent was selected for use.However, during unpacking, it was noted that the proximal end of the stent struts were peeled back.The procedure was completed with another stent.No patient complications were reported and patient's status is okay.

• 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: 6808248
• Report Number: 2134265-2017-08298
• Device Sequence Number: 149672
• Product Code: NIQ
• UDI-Device Identifier: 08714729840046
• UDI-Public: (01)08714729840046(17)20180403(10)0020509166
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/02/2017

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: 04/03/2018
• Device Model Number: H7493926012270
• Device Catalogue Number: 39260-1227
• Device Lot Number: 0020509166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 08/21/2017
• Supplement Report FDA Received Date: 09/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1