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

Model Number	10601
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Date of event: used the first date of the month of the reported occurrence provided ((b)(6) 2019).
Event or Problem Description
Reported via voluntary medwatch # (b)(4).It was reported that shaft break occurred the target lesion was located in circumflex artery.A 3.50 x 12mm synergy ii drug-eluting stent was advanced over a 180cm non bsc guidewire but failed to cross the lesion.A second non bsc guidewire was added as a "buddy wire" and another attempt was made to cross the lesion but was unsuccessful.The synergy device was removed from the patient and laid out straight on the table off to the side.A 6fr guide liner was inserted for more support and the buddy wire was removed.The synergy device was then loaded back on the guidewire but during advancement, it was noticed that the shaft of the catheter did not look right.Upon removing the stent, the distal 60% of the stent shaft separated from the rest of the catheter, leaving approximately 40% in the patient with about 12 inches sticking out of the hub of the access sheath.The physician was able to remove the remaining portion of the stent catheter completely and the procedure was completed with a different device without any 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: 9260422
• Report Number: 2134265-2019-13240
• Device Sequence Number: 14367504
• Product Code: NIQ
• UDI-Device Identifier: 08714729840060
• UDI-Public: 08714729840060
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2019

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 Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0022705530
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR