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

Model Number	10603
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent damage occured.The physician attempted to pass 2.25 x 20 synergy drug-eluting stent through an internal mammary graft to the distal left anterior descending artery.The stent was unable to completely advance and it was removed so that the area of the vessel could be predilated.When the stent was removed it was noted that one of the stent struts on proximal portion of the stent was damaged.The procedure was completed with a 2.25 x 16 synergy drug-eluting stent.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 2.25 x 20 mm stent delivery system was returned for analysis.A visual examination of the stent found that on the first two proximal stent strut row, the stent struts were lifted and pulled outwards.The undamaged section of the crimped stent outer diameter 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 tip showed no signs of damage.A visual and tactile examination of the hypotube found no issues with the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and visual examination of the inner extrusion shaft found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent damage occurred.The physician attempted to pass 2.25 x 20 synergy drug-eluting stent through an internal mammary graft to the distal left anterior descending artery.The stent was unable to completely advance and it was removed so that the area of the vessel could be predilated.When the stent was removed it was noted that one of the stent struts on proximal portion of the stent was damaged.The procedure was completed with a 2.25 x 16 synergy drug-eluting stent.No patient complications nor injuries were reported.

• 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: 9427683
• Report Number: 2134265-2019-15179
• Device Sequence Number: 534063
• Product Code: NIQ
• UDI-Device Identifier: 08714729840145
• UDI-Public: 08714729840145
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/07/2020

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 Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0024228563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1