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 Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed, de novo target lesion was located in the moderately tortuous and heavily calcified left anterior descending artery and diagonal bifurcation lesion.Following pre-dilation of 6 different balloons, a spiral dissection was noted and a 2.50 x 28mm synergy drug-eluting stent was advanced to treat the lesion distally.It was pushed hard causing the hypotube to break.Another 2.50x28mm synergy stent was used but had the same issue.The procedure was completed with another synergy stent.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed, de novo target lesion was located in the moderately tortuous and heavily calcified left anterior descending artery and diagonal bifurcation lesion.Following pre-dilation of 6 different balloons, a spiral dissection was noted and a 2.50 x 28mm synergy drug-eluting stent was advanced to treat the lesion distally.It was pushed hard causing the hypotube to break.Another 2.50x28mm synergy stent was used but had the same issue.The procedure was completed with another synergy stent.No patient complications were reported.It was further reported that all 6 balloons used during pre-dilation were non-bsc devices.
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed, de novo target lesion was located in the moderately tortuous and heavily calcified left anterior descending artery and diagonal bifurcation lesion.Following pre-dilation of 6 different balloons, a spiral dissection was noted and a 2.50 x 28mm synergy drug-eluting stent was advanced to treat the lesion distally.It was pushed hard causing the hypotube to break.Another 2.50x28mm synergy stent was used but had the same issue.The procedure was completed with another synergy stent.No patient complications were reported.It was further reported that all 6 balloons used during pre-dilation were non-bsc devices.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr synergy ii us mr 2.50 x 28mm stent delivery system (sds) 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 od(outer diameter) was measured and the result is 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 a break 19cm distal to the distal end of the strain relief, multiple hypotube 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.

• 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: 8182283
• Report Number: 2134265-2018-64512
• Device Sequence Number: 11243026
• Product Code: NIQ
• UDI-Device Identifier: 08714729840275
• UDI-Public: 08714729840275
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 03/04/2019

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: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0022551532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 12/17/2018; 02/12/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 01/15/2019; 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1