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

Model Number	10622
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent damage occurred.A 4.50 x 32 synergy ii drug-eluting stent was advanced for treatment.However, it was noted that the stent was damaged as the physician was trying to deliver or pass it through the guidezilla guide extension catheter.No information on how was the procedure completed.No patient complications were reported.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 4.50 x 32 mm stent delivery system was returned for analysis.An examination of the crimped stent found stent damage.Stent struts from mid-section to distal stent strut rows were noted to be lifted from their crimped position and pulled in all directions.The undamaged crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.Stent damage most likely occurred during attempts to advance/ withdraw the device trough the guide catheter.The balloon was 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.This type of damage is most likely caused when pushing the device against a resistance.A visual and tactile examination of the hypotube found multiple hypotube kinks along several locations of the hypotube shaft.This type of damage is consistent with excessive force that could have been applied to the delivery system.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
It was reported that stent damage occurred.A 4.50 x 32 synergy ii drug-eluting stent was advanced for treatment.However, it was noted that the stent was damaged as the physician was trying to deliver or pass it through the guidezilla guide extension catheter.No information on how was the procedure completed.No patient complications were reported.

• 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: 8844127
• Report Number: 2134265-2019-09008
• Device Sequence Number: 10814419
• Product Code: NIQ
• UDI-Device Identifier: 08714729973393
• UDI-Public: 08714729973393
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2019

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: 01/20/2021
• Device Model Number: 10622
• Device Catalogue Number: 10622
• Device Lot Number: 0023260607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 09/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1