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

Model Number	10605
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that shaft break occured.The 80% stenosed target lesion was located in the severely tortuous distal right coronary artery.A 4.00mm x 28mm synergy ii drug-eluting stent was advanced for treatment, but failed to cross the lesion.The physician took it out of the patient's body and then advanced it again for the second time.Upon advancing, the physician noticed that the catheter of the stent was broken.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.The 80% stenosed target lesion was located in the severely tortuous distal right coronary artery.A 4.00mm x 28mm synergy ii drug-eluting stent was advanced for treatment, but failed to cross the lesion.The physician took it out of the patient's body and then advanced it again for the second time.Upon advancing, the physician noticed that the catheter of the stent was broken.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device is a combination product.A synergy ii us mr 4.00 x 28mm stent delivery system was returned for analysis.A visual and microscopic 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 between the proximal and distal markerbands.The crimped stent od (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 no signs of damage.A visual and tactile examination of the hypotube found multiple kinks on several locations of the hypotube shaft, and a hypotube break located 51.5cm distal to the distal strain relief.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.

• 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: 8716232
• Report Number: 2134265-2019-07210
• Device Sequence Number: 1992548
• Product Code: NIQ
• UDI-Device Identifier: 08714729840312
• UDI-Public: 08714729840312
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 07/10/2019

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: 11/11/2020
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0022969992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1