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

Model Number	10602
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the ostial circumflex artery.A 2.25 x 16 synergy drug- eluting stent was advanced for treatment.However, during the procedure, the stent came off the balloon inside the circumflex artery.The physician ended up having to crush it against another stent.The procedure was completed with different device.No further patient complications reported.
Additional Manufacturer Narrative
(b3) date of event corrected from(b)(6)2020 to (b)(6)2020.Device is a combination product.
Event or Problem Description
It was reported via medwatch(b)(4) that stent dislodgement occurred.The target lesion was located in the ostial circumflex artery.A 2.25 x 16 synergy drug- eluting stent was advanced for treatment.However, during the procedure, the stent came off the balloon inside the circumflex artery.The physician ended up having to crush it against another stent.The procedure was completed with different device.No further patient complications reported.

• 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: 9750699
• Report Number: 2134265-2020-01953
• Device Sequence Number: 1367707
• Product Code: NIQ
• UDI-Device Identifier: 08714729840084
• UDI-Public: 08714729840084
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2020

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: 11/10/2021
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0024782316
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 03/25/2020
• 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