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 Consequences Or Impact To Patient (2199)
Date of Event	04/09/2019
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 95% stenosed target lesion was located in the severely tortuous and moderately calcified right coronary artery (rca).After the 2.5 x 38mm synergy drug-eluting stent was implanted in the proximal rca, post-dilation was performed with a 2.75 x 10 non-bsc balloon catheter.A 2.25 x 16mm synergy drug-eluting stent was attempted to pass through the implanted stent, however it was noted that the stent hung and then dislodged from stent delivery system.The dislodged stent was deployed with a 2.5x20 non-bsc device.There were no patient complications reported and the patient's status was stable.

• 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: 8570119
• Report Number: 2134265-2019-04547
• Device Sequence Number: 2346367
• Product Code: NIQ
• UDI-Device Identifier: 08714729840084
• UDI-Public: 08714729840084
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2019

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: 01/08/2021
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0023196799
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 05/01/2019
• 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
• Patient Age: 62 YR