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

Model Number	10605
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.A 2.50 x 28mm synergy drug-eluting stent was selected for used; however; the stent was no longer mounted onto the catheter when the stylet was removed.The procedure was completed with another of the same device and no patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy ii us mr 2.50 x 28mm stent delivery system was returned for analysis in 2 sections with the mandrel and stent protector attached, the mandrel was kinked at the port bond site.Mandrel pigtail cut to allow removal of stent protector and visual examination of stent.An examination of the crimped stent found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The crimped stent outer diameter was measured and the result is within max crimped stent profile measurement.No damage to the balloon was noted.Crimp stent markings were visible on the exposed balloon wall without any signs of positive pressure applied to balloon.The balloon wings were tightly wrapped and folded.A visual examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual examination of the outer and inner lumen and mid-shaft section found a break 118.7cm distal to the distal end of strain relief at the port bond and damage to the port bond site with a tear in the plymer extrusion.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent dislodgement occurred.A 2.50 x 28mm synergy drug-eluting stent was selected for used; however; the stent was no longer mounted onto the catheter when the stylet was removed.The procedure was completed with another of the same device and no patient complications were reported.Previously, it was reported that the stent was dislodged.Now, it is reported that stent damage occurred.

• 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: 10928146
• Report Number: 2134265-2020-16565
• Device Sequence Number: 4295629
• Product Code: NIQ
• UDI-Device Identifier: 08714729840275
• UDI-Public: 08714729840275
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 01/27/2021

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: 11/12/2021
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0024816287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1