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

Model Number	10602
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is combination product.The distal section of the shaft including the stent was not returned for analysis therefore analysis of stent profile could not be carried out.However, as part of the analysis, a review of the manufacturing data for the stent profile was performed.The distal section of the shaft including the balloon was not returned for analysis therefore analysis of balloon profile could not be carried out.The distal section of the shaft including the tip was not returned for analysis therefore analysis of tip profile could not be carried out.A visual and tactile examination of the hypotube found multiple severe kinks along several locations of the hypotube shaft.This type of damage is consistent with excessive force that could have been applied on the delivery system.A visual and tactile examination of the mid-shaft section found a break at the wire exit port/port bond.The distal section of the shaft was not returned for analysis.It appears as if the shaft was cut off as there is no evidence of shaft stretching indicating that excessive force was not applied to cause the break.A kink was also noted on the port bond.The cause of the shaft break cannot be determined the cause of the shaft break due to limited information provided in the complaint report.
Event or Problem Description
Reportable based on device analysis completed on 10jan2020.It was reported that device could not cross lesion.Following pre-dilatation with a 2.5x14mm emerge mr balloon, a 2.50 x 16 synergy ii drug eluting stent was unable to cross the lesion.No patient complications were reported.However, device analysis revealed shaft break.

• 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: 9642606
• Report Number: 2134265-2020-00670
• Device Sequence Number: 2001682
• Product Code: NIQ
• UDI-Device Identifier: 08714729840091
• UDI-Public: 08714729840091
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/29/2020

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 Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0024377318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1