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

Model Number	10602
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used (b)(6) 2019 as no event date was provided.Device is a combination product.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 3.50 x 16 synergy drug-eluting stent was advanced over a wire for treatment; however, the shaft snapped.The procedure was completed with another of the same device.There were no patient complications reported and the patient was fine.
Additional Manufacturer Narrative
(b3) date of event: used (b)(6) 2019 as no event date was provided.Device is a combination product.Device evaluted by mfr.:synergy ii us mr 3.50 x 16mm stent delivery system was returned for analysis in 2 pieces.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 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 tactile examination of the hypotube found a hypotube break located 74cm distal to the distal strain relief, as well as multiple hypotube kinks at several locations along the hypotube shaft.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.A visual and microscopic examination of the bumper tip showed distal tip damage.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 3.50 x 16 synergy drug-eluting stent was advanced over a wire for treatment; however, the shaft snapped.The procedure was completed with another of the same device.There were no patient complications reported and the patient 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: 9136549
• Report Number: 2134265-2019-11769
• Device Sequence Number: 19528611
• Product Code: NIQ
• UDI-Device Identifier: 08714729840121
• UDI-Public: 08714729840121
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/07/2019

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: 05/12/2021
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0023826380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1