MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT

Model Number	10619
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 4.50 x 20 mm stent delivery system was returned for analysis broken 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 microscopic examination of the bumper tip showed signs of damage on the distal end of the tip.A visual and tactile examination of the hypotube shaft found a break situated at 23.2 cm distal to the distal end of the strain relief as well as multiple hypotube kinks immediately distal and proximal to the breaking site.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 30jan2020.It was reported that the shaft broke in a portion that could not enter the patient's body.The 75% stenosed target lesion was located in the mildly tortuous and non-calcified left anterior descending artery (lad).After placing a 6fr ebu 3.5 non-bsc guide catheter and a non-bsc wire in the proximal lad, a 4.50x20mm synergy ii drug-eluting stent was advanced to treat a moderate thrombus but the shaft snapped at the hub.The device was completely removed.The procedure was completed with another non-bsc wire and another 4.5x20mm synergy stent of same.No patient complications were reported and the patient was doing great.However, returned device analysis revealed hypotube separation.

• Brand Name: SYNERGY
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9732964
• Report Number: 2134265-2020-01550
• Device Sequence Number: 10864956
• Product Code: NIQ
• UDI-Device Identifier: 08714729973362
• UDI-Public: 08714729973362
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003/S039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2020

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: 11/04/2020
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0022914482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1