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

Model Number	10602
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The 90% stenosed target lesion was located in the mildly tortuous and non-calcified proximal saphenous vein graft.A 4.00x16mm synergy drug-eluting stent was advanced but failed to be delivered twice.On the third attempt, the stent came off the balloon shaft.Snaring was attempted but failed.The physician was able to advance a 2.0 mm emerge balloon catheter to inflate the undeployed stent and serial inflations with multiple balloons was also performed to fully deploy stent.Post intravasculat ultrasound confirmed that the stent was fully deployed.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
A synergy ii us mr 4.00 x 16 mm stent delivery system was returned for analysis without the stent.A review of the manufacturing stent profile data was performed and the stent outer diameter at the time of manufacture was within max crimped stent profile measurement.The balloon cones were reviewed, and no signs of positive pressure applied to the cones were noted however their wings were not tightly folded.Crimp markings were noted on the exposed balloon body.A visual and microscopic examination of the bumper tip showed signs of tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks along several locations of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent dislodgement occurred.The 90% stenosed target lesion was located in the mildly tortuous and non-calcified proximal saphenous vein graft.A 4.00x16mm synergy drug-eluting stent was advanced but failed to be delivered twice.On the third attempt, the stent came off the balloon shaft.Snaring was attempted but failed.The physician was able to advance a 2.0 mm emerge balloon catheter to inflate the undeployed stent and serial inflations with multiple balloons was also performed to fully deploy stent.Post intravasculat ultrasound confirmed that the stent was fully deployed.The procedure was completed with a different device.No patient complications 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: 10449982
• Report Number: 2134265-2020-10881
• Device Sequence Number: 14281904
• Product Code: NIQ
• UDI-Device Identifier: 08714729840138
• UDI-Public: 08714729840138
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/09/2022
• Device Model Number: 10602
• Device Catalogue Number: 10602
• Device Lot Number: 0025217958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 08/25/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention