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

Model Number	10605
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: patient is over 65 years old.Device is a combination product.
Event or Problem Description
It was reported that stent dislodgment occurred.The target lesion was located in the calcified and tortuous circumflex artery.A 3.50 x 28mm synergy stent was advanced but failed to cross due to tortuosity.A guidezilla guide extension catheter was then advanced for support.However, when the device was advanced out of the guidezilla towards the lesion, the stent sheared off from the balloon.An emerge balloon was inflated to pin the stent in place.Bifemoral access was stuck and a second 7f non-bsc guide catheter was used with a gooseneck snare.The snare captured the end of the stent floating in the aorta, and the inflated balloon pinning the stent was deflated after the gooseneck captured the stent.The stent was pulled through the non-bsc guide catheter and out of the body.A 3.0 x 15mm nc quantum apex was advanced for dilatation and the procedure was completed with a 3.5x28mm synergy stent.No patient complications were reported and the patient's status was fine.

• 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: 7895643
• Report Number: 2134265-2018-61158
• Device Sequence Number: 19269320
• Product Code: NIQ
• UDI-Device Identifier: 08714729840305
• UDI-Public: 08714729840305
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 09/20/2018

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 Expiration Date: 06/06/2020
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0022245213
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 09/20/2018
• 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