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

Model Number	10600
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that shaft break occurred.A 2.50 x 8 synergy drug eluting stent was selected for use to treat the lesion.As the device was inserted into the guide, it was noted that the device was kinked.When the device was pulled out, the shaft eventually broke in half.The device never entered the patient's body.The procedure was completed with another of the same device.No complications were reported.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 2.50 x 8mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The crimped stent outer diameter was measured within max 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 damage.A visual and tactile examination of the hypotube found two breaks, one 12.5cm and another 55cm distal to the distal end of the strain relief.Multiple kinks were also noted.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that shaft break occurred.A 2.50 x 8 synergy drug eluting stent was selected for use to treat the lesion.As the device was inserted into the guide, it was noted that the device was kinked.When the device was pulled out, the shaft eventually broke in half.The device never entered the patient's body.The procedure was completed with another of the same device.No complications were reported.It was further reported that the device broke at the wire exit port.The patient's status was fine.

• 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: 8314954
• Report Number: 2134265-2019-00903
• Device Sequence Number: 16160818
• Product Code: NIQ
• UDI-Device Identifier: 08714729839972
• UDI-Public: 08714729839972
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 03/25/2019

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: 08/14/2020
• Device Model Number: 10600
• Device Catalogue Number: 10600
• Device Lot Number: 0022556120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 02/07/2019
• Supplement Report FDA Received Date: 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1