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

Model Number	10604
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in the circumflex artery.After deploying a 3.00x24mm synergy drug-eluting stent, the delivery system was attempted to be removed; however, the delivery system caught with the guide and could not be removed.A non-bsc extension catheter was used to free the device from the guide but was unsuccessful.The physician decided pull everything out.New access was obtained and the procedure was completed.No patient complications were reported and the patient was doing well.
Additional Manufacturer Narrative
Device evaluated by mfr.Synergy ii us mr 3.00 x 24 mm stent delivery system was returned for analysis.The stent was not returned for analysis.The stent was deployed in the patient's body as per complaint report.The balloon body filled with brownish substance resembling blood.There was no stent on the balloon.The balloon appeared bunched on the distal section.A visual and microscopic examination of the tip showed no signs of damage.A visual and tactile examination of the hypotube multiple kinks along several locations of the hypotube shaft.This type of damage is consistent with excessive force that might have been applied on the delivery system.A visual and tactile examination of the outer extrusion and mid-shaft section and visual examination of the inner extrusion found a shaft polymer extrusion break at the port bond (120 mm distal of the midshaft-hypotube bond) and the shaft polymer extrusion was stretched at the break site.This type of damage is consistent with excessive force that might have been applied on the delivery system.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in the circumflex artery.After deploying a 3.00x24mm synergy drug-eluting stent, the delivery system was attempted to be removed; however, the delivery system caught with the guide and could not be removed.A non-bsc extension catheter was used to free the device from the guide but was unsuccessful.The physician decided pull everything out.New access was obtained and the procedure was completed.No patient complications were reported and the patient was doing well.

• 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: 10638080
• Report Number: 2134265-2020-13099
• Device Sequence Number: 3159067
• Product Code: NIQ
• UDI-Device Identifier: 08714729840237
• UDI-Public: 08714729840237
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 11/19/2020

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: 03/10/2022
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0025411184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 11/19/2020
• 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: Other
• Patient Age: 74 YR