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

Model Number	10601
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Death (1802); Stenosis (2263); No Code Available (3191)
Date of Event	08/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient died.The 50% stenosed target lesion was located in the non-calcified and severely tortuous left internal mammary artery to distal left anterior descending artery.A 2.25x16mm synergy ii drug-eluting stent was advanced but failed to cross the lesion.Subsequently, a 2.25x12mm synergy ii drug-eluting stent was used but had difficulty advancing.The device was attempted to remove but the stent was dislodged at the anastomosis.A 2.0x12mm emerge balloon catheter was advanced and deploy the stent with two inflations at 18 atmospheres for 16 seconds each.Afterwards, a slow flow down in the vessel was observed.Nitroglycerin was given to restore normal blood flow; however, the vessel still had slow flow.The physcian tried going back in with an interventional wire to balloon it up but it ended leaving it as is.The patient was transferred to the floor and later in the afternoon, the patient coded and expired later the same night.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 2.25 x 12 stent delivery system was returned for analysis.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.Crimp mark are visible on the exposed balloon.A visual and microscopic examination of the bumper tip showed signs of tip damage.A visual and tactile examination of the hypotube found multiple kinks.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.A 0.0140'' guidewire inserted through distal tip but met an obstruction approximately 225mm distal to distal tip.The device soaked in a waterbath for 24 hours.After a 0.0140'' guidewire was inserted through distal tip and exited the port bond without issue.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the patient died.The 50% stenosed target lesion was located in the non-calcified and severely tortuous left internal mammary artery to distal left anterior descending artery.A 2.25x16mm synergy ii drug-eluting stent was advanced but failed to cross the lesion.Subsequently, a 2.25x12mm synergy ii drug-eluting stent was used but had difficulty advancing.The device was attempted to remove but the stent was dislodged at the anastomosis.A 2.0x12mm emerge balloon catheter was advanced and deploy the stent with two inflations at 18 atmospheres for 16 seconds each.Afterwards, a slow flow down in the vessel was observed.A nitro was given to restore normal blood flow; however, the vessel still had slow flow.The physician tried going back in with an interventional wire to balloon it up but it ended leaving it as is.Thereafter, the patient was coded later afternoon once patient was transferred to the floor and eventually died later the same night.

• 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: 10449978
• Report Number: 2134265-2020-10887
• Device Sequence Number: 11592185
• Product Code: NIQ
• UDI-Device Identifier: 08714729840022
• UDI-Public: 08714729840022
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/01/2020

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: 09/25/2021
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0024579134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 10/01/2020
• 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: Death; Hospitalization; Required Intervention
• Patient Age: 74 YR