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 with 6 different balloons, a 2.50 x 28mm synergy drug-eluting stent was advanced to treat a spiral dissection.The device was pushed very hard causing the hypotube to break in half.Another 2.50x28mm synergy stent was used but also broke in half.The procedure was completed with another 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 with 6 different balloons, a 2.50 x 28mm synergy drug-eluting stent was advanced to treat a spiral dissection.The device was pushed very hard causing the hypotube to break in half.Another 2.50x28mm synergy stent was used but also broke in half.The procedure was completed with another stent.No patient complications were reported.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 2.50 x 28 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 is 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 a hypotube break 91.3 cm distal from the distal end of the strain relief.Multiple hypotube kinks were also noted.A visual and tactile examination of the shaft polymer extrusion found no issues along the midshaft or inner or outer 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: 8184752
• Report Number: 2134265-2018-64511
• Device Sequence Number: 13817757
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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: 02/07/2019
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1