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

Model Number	10602
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent damage occurred.An ffr was performed with a boston scientific comet ii pressure guidewire and the ffr result was positive.The back end handle was removed from the comet ii pressure guidewire so it could be used as the interventional wire.A 2.25 x 16 synergy stent was loaded onto the backend of the guidewire.While loading the device, the wire slipped and caused one of the stent struts to become damaged.The proximal stent strut was sticking up.The stent was set aside and the procedure was completed with another of the same device.The case was finished without any further complications.
Additional Manufacturer Narrative
Device evaluated by mfr: a 2.25 x 16mm synergy ii stent delivery system was returned for analysis.A visual examination of the stent found that stent struts at the distal end of the stent were lifted and pulled proximally.The undamaged section of the crimped stent od (outer diameter) was measured and the result was within maximum crimped stent profile measurement.Stent damage most likely occurred when the stent interacted with the guidewire during loading of the guidewire attempts.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 multiple kinks along several locations of the hypotube shaft.This type of damage is consistent with excessive force that could have been applied on the delivery system.A visual and tactile examination of the outer and mid shaft section and visual examination of the inner extrusion shaft found multiple kinks along several locations along the shaft polymer extrusion.This type of damage is consistent with excessive force that could have been applied on the delivery system.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent damage occurred.An ffr was performed with a boston scientific comet ii pressure guidewire and the ffr result was positive.The back end handle was removed from the comet ii pressure guidewire so it could be used as the interventional wire.A 2.25 x 16 synergy stent was loaded onto the backend of the guidewire.While loading the device, the wire slipped and caused one of the stent struts to become damaged.The proximal stent strut was sticking up.The stent was set aside and the procedure was completed with another of the same device.The case was finished without any further complications.

• 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: 10471034
• Report Number: 2134265-2020-11978
• Device Sequence Number: 2889567
• Product Code: NIQ
• UDI-Device Identifier: 08714729840084
• UDI-Public: 08714729840084
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/06/2020

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: 08/27/2021
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0024372803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1