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

Model Number	10601
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	Vascular Dissection (3160); No Code Available (3191)
Date of Event	02/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that vessel dissection occurred.The target lesion was located in the moderately tortuous and non calcified right coronary artery.A 2.50 x 12 synergy drug-eluting stent was selected for use but failed to advanced into the lesion.A vessel dissection was noted during procedure.No further patient complications were reported.
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that vessel dissection occurred.The target lesion was located in the moderately tortuous and non calcified right coronary artery.A 2.50 x 12 synergy drug-eluting stent was selected for use but failed to advanced into the lesion.A vessel dissection was noted during procedure.No further patient complications were reported.It was further reported that after the device was advanced into the patient, a non-flow limiting dissection.The physician placed a new stent to treat the event.However, the patient was sent to an outline facility for surgery as the dissection started to progressed up into the aorta.After that, the patient's status was good.

• 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: 8412759
• Report Number: 2134265-2019-02267
• Device Sequence Number: 303341
• Product Code: NIQ
• UDI-Device Identifier: 08714729840039
• UDI-Public: 08714729840039
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 04/01/2019

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: 09/30/2020
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 22760261
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 04/01/2019
• 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: Other
• Patient Age: 50 YR
• Patient Weight: 69