MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	10606
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in a highly calcified coronary artery.A 2.50 x 32mm synergy ii drug-eluting stent was advanced but failed to cross the lesion.When the device was removed, it was noted that the stent struts were lifted.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in a highly calcified coronary artery.A 2.50 x 32mm synergy ii drug-eluting stent was advanced but failed to cross the lesion.When the device was removed, it was noted that the stent struts were lifted.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 2.50 x 32mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent identified stent damage.Damage was noted to the distal end of the stent.The undamaged crimped stent outer diameter 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.The balloon had not been subjected to positive pressure.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of shaft polymer extrusion revealed no issues.A visual and microscopic examination found damage to the tip.No other issues were identified during the product analysis.

• Brand Name: SYNERGY
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8254694
• Report Number: 2134265-2018-65188
• Device Sequence Number: 1952950
• Product Code: NIQ
• UDI-Device Identifier: 08714729840336
• UDI-Public: 08714729840336
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 02/27/2019

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: 08/08/2020
• Device Model Number: 10606
• Device Catalogue Number: 10606
• Device Lot Number: 0022517984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Initial Date Received by Manufacturer: 12/26/2018
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1