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	H7493926038220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr.: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the moderately tortuous and severely calcified circumflex artery.A non-bsc device was used to prepare the lesion.A non-bsc guidewire was placed and following pre-dilation of a 2.5 nc emerge balloon catheter, a 2.25 x 38mm synergy ii drug-eluting stent was advanced but failed to cross the lesion.When the device was removed, a small kink in the distal shaft of the device was noted.The same stent was inserted back through the non-bsc bleedback control valve and it was able to cross the lesion.When trying to inflate the balloon of the device, it would not inflate.The device was removed from the patient's body and it was noted that the stent delivery system (sds) with mounted undeployed stent had separated at the proximal end of the balloon and remained in the vessel.The non-bsc wire that was used had also sheared off, leaving the distal tip of the wire in the body.It took two hours trying to snare the detached component of the sds and wire but it was unsuccessful.The procedure was completed with a different device.No further patient complications were reported and the patient's status was stable.

• 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: 7114543
• Report Number: 2134265-2017-12130
• Device Sequence Number: 1874311
• Product Code: NIQ
• UDI-Device Identifier: 08714729840381
• UDI-Public: 08714729840381
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/06/2018
• Device Model Number: H7493926038220
• Device Catalogue Number: 39260-3822
• Device Lot Number: 0021126054
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention