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

Model Number	10603
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent movement on balloon occurred.A 3.00 x 20 synergy drug-eluting stent was advanced but failed to cross the lesion.However, it was noted that the stent had a section near one end of the balloon that was off the balloon and had a segment sticking up.The procedure was completed with another synergy stent and there were no patient complications reported.
Event or Problem Description
It was reported that stent movement on balloon occurred.A 3.00 x 20 synergy drug-eluting stent was advanced but failed to cross the lesion.However, it was noted that the stent had a section near one end of the balloon that was off the balloon and had a segment sticking up.The procedure was completed with another synergy stent and there were no patient complications reported.It was further reported that the distal end of the stent was sticking up after withdrawal from the patient.
Additional Manufacturer Narrative
Device is a combination product.B5 - describe event or problem updated.

• 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: 10264632
• Report Number: 2134265-2020-09224
• Device Sequence Number: 3463432
• Product Code: NIQ
• UDI-Device Identifier: 08714729840176
• UDI-Public: 08714729840176
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 08/28/2020

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: 02/09/2022
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0025220619
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1