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	04/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occured.The target lesion was located in the radial artery.A 2.50 x 12 synergy drug-eluting stent was selected for use.The physician was trying to remove the stent through the tuohy but the shaft broke 33.2cm from the hub.The monorail section broke as well, it was all in the guide catheter.This happened after the device was completely removed from the patient.The procedure was completed with this device.There were no patient complications nor serious injury reported.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.; synergy ii us mr 2.50 x 12 mm stent delivery system was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal markerbands.The crimped stent outer diameter was measured and the result was within maximum crimped stent profile measurement.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 microscopic examination of the bumper tip showed signs of damage.Tip damage most likely occurred when the tip was pushed against a restriction.A visual and tactile examination of the found a hypotube break at 22.5 cm distal from the distal end of the strain relief.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 outer extrusion and mid-shaft section and a visual examination of the inner extrusion found a shaft polymer extrusion break at 26 cm from the distal tip.This type of damage is consistent with excessive force that could have been applied on the delivery system.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that shaft break occured.The target lesion was located in the radial artery.A 2.50 x 12 synergy drug-eluting stent was selected for use.The physician was trying to remove the stent through the tuohy but the shaft broke 33.2cm from the hub.The monorail section broke as well, it was all in the guide catheter.This happened after the device was completely removed from the patient.The procedure was completed with this device.There were no patient complications nor serious injury 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: 8569364
• Report Number: 2134265-2019-04631
• Device Sequence Number: 1809794
• Product Code: NIQ
• UDI-Device Identifier: 08714729840039
• UDI-Public: 08714729840039
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 07/01/2019

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: 09/16/2020
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0022684126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1