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	H7493926032400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device is a combination product.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 4.00 x 32mm synergy ii drug-eluting stent was advanced to treat the lesion.However, it was noted that shaft broke at the guide wire exit port.The device was removed along with the guide catheter and guide wire as one unit.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
Synergy ii us mr 4.00 x 32mm stent delivery system (sds) was returned for analysis without a stent.The balloon was reviewed.There was no stent on the balloon.The balloon folds were open and it appeared that the balloon had been inflated and deflated.There appeared to be blood in balloon it is most likely the blood entered the balloon when the shaft polymer extrusion broke inside the patient.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of the shaft polymer extrusion revealed a break in shaft polymer extrusion at the port bond, 272mm proximal to distal edge of tip.The corewire was exposed.There appeared to be blood in shaft polymer extrusion, it is most likely the blood entered the extrusion when the shaft polymer extrusion broke inside the patient.A visual and microscopic examination found damage to the 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 operational context as device performance was limited due to anatomical procedural factors.(b)(4).
Event or Problem Description
It was further reported that the stent was implanted and the event happened upon removal of the stent delivery system from the patient.

• 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: 6584133
• Report Number: 2134265-2017-05218
• Device Sequence Number: 13551987
• Product Code: NIQ
• UDI-Device Identifier: 08714729840374
• UDI-Public: (01)08714729840374(17)20171010(10)0019834093
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2017

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: 10/10/2017
• Device Model Number: H7493926032400
• Device Catalogue Number: 39260-3240
• Device Lot Number: 0019834093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2017
• Supplement Report FDA Received Date: 06/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1