MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT

Lot Number	0026909858
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	06/21/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient died.A 2.25 x 24mm synergy xd drug-eluting stent was deployed in the left main (lm); however, the stent migrated into the proximal left circumflex artery and was deployed where it was.During deployment, the ostial lm part of the stent had proximal stent edge shortening and a 3.00 x 24mm synergy xd drug-eluting stent was deployed at the original lesion, overlapping with the first stent.A recommendation was made for completion of the left main bifurcation stenting due to the bunching of the stent within the ostial left main.Seven days later, the patient returned to the cath lab on vasopressin and phenylephrine.During this procedure, a 3.50 x 12mm synergy xd drug-eluting stent was placed in the left anterior descending artery to lm.During proximal optimization technique on the left main portion of the stent, there was again stent edge shortening.Two days later the patient died.The primary cause of death was non-st-elevation myocardial infarction (nstemi).

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17484577
• Report Number: 2124215-2023-39632
• Device Sequence Number: 20667974
• Product Code: NIQ
• UDI-Device Identifier: 08714729981039
• UDI-Public: 08714729981039
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2023

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: 02/22/2023
• Device Lot Number: 0026909858
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 61 YR
• Patient Sex: Female