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	H7493926038270
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.The target lesion was located in a coronary artery.A 2.75x38mm synergy ii drug-eluting stent was advanced to treat the lesion.However, after device was inserted into the guide catheter, it was noticed that the stent struts were deformed.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.Synergy ii us mr 2.75 x 38mm stent delivery system was returned for analysis.A visual examination of the crimped stent revealed damage to the central struts.The proximal and distal sections of the stent were undamaged.The undamaged crimped stent outer diameter was measured and was within maximum crimped stent profile measurement.The balloon cones were reviewed and it was noted that the distal balloon cone was tightly wrapped and evenly folded.The proximal balloon cone was out of its original folded position due to the damage to the stent.A visual and tactile examination of the device revealed multiple hypotube kinks.An examination of the shaft polymer extrusion found no issues.The bi-component bond showed no signs of damage.The tip was visually and microscopically examined and no issues were noted.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 caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in a coronary artery.A 2.75x38mm synergy ii drug-eluting stent was advanced to treat the lesion.However, after device was inserted into the guide catheter, it was noticed that the stent struts were deformed.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: 7053022
• Report Number: 2134265-2017-11406
• Device Sequence Number: 1091796
• Product Code: NIQ
• UDI-Device Identifier: 08714729840404
• UDI-Public: 08714729840404
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 11/02/2017

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: 06/13/2018
• Device Model Number: H7493926038270
• Device Catalogue Number: 39260-3827
• Device Lot Number: 0020789510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Initial Date Received by Manufacturer: 11/02/2017
• Supplement Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1