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

Model Number	10607
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: synergy ii us mr 3.50 x 38 mm stent delivery system was returned for analysis.A visual examination of the stent found the proximal stent strut struts were lifted from their crimped stent position.The undamaged crimped stent od (outer diameter) was measured and the result was within maximum crimped stent profile measurement.Stent damage most likely occurred during withdrawal attempts.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination of the outer extrusion and mid-shaft section and visual inspection of the inner extrusion found that the shaft polymer extrusion was stretched at 19.5 cm distal from the port bond.This type of damage is consistent with excessive force that could have been applied on the delivery system.
Event or Problem Description
Reportable based on device analysis completed on 14-jun-2019.It was reported that crossing difficulties were encountered.The target lesion was located in the coronary artery.A 3.50 x 38 synergy ii us mr stent was selected for use.During percutaneous coronary intervention, it was noted that the synergy us mr stent could not cross the lesion.The procedure was completed with another of the same device.No patient complications were reported.However, returned device analysis revealed stent damage.

• 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: 8764625
• Report Number: 2134265-2019-07861
• Device Sequence Number: 11393876
• Product Code: NIQ
• UDI-Device Identifier: 08714729840428
• UDI-Public: 08714729840428
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/05/2019

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 Expiration Date: 07/17/2020
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0022433900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 07/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1