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	H7493926016270
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr.: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that stent dislodgment occurred.Vascular access was obtained via the right femoral artery.The target lesion was located in the non-tortuous and mildly calcified proximal left circumflex artery (lcx).A 2.75 x 16 synergy ii drug-eluting stent was advanced but failed to cross the lesion and was pulled back into the guide.Under fluoroscopy, it was noted that the undeployed stent was in the left main/proximal left anterior descending artery.It was then verified that the stent was not on the delivery system.The proximal guide catheter was noted to be kinked and was exchanged.An unsuccessful snaring attempt was made using a non-bsc snare kit.Access to the lcx was regained using a non-bsc wire and 1.2 x 8 mm balloon.The wire was exchanged and a 2.5 x 15 mm nc emerge balloon catheter was used to pin the stent against the vessel wall.The procedure was completed by deploying a 3.0x16 synergy stent in the proximal lcx.No patient complications were reported and the patient 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: 7264639
• Report Number: 2134265-2018-00738
• Device Sequence Number: 13821837
• Product Code: NIQ
• UDI-Device Identifier: 08714729840107
• UDI-Public: 08714729840107
• 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
• Report Date (Section B): 01/18/2018

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 Model Number: H7493926016270
• Device Catalogue Number: 39260-1627
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: FORTE; INTRODUCER SHEATH: 6F PINNACLE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR