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

Lot Number 0026909858

Device Problem Defective Device (2588)

Patient Problem Myocardial Infarction (1969)

Event Date 06/21/2023

Event Type  Death  

Event 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
• Type of Device: 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
• MDR Text Key: 320651113
• Report Number: 2124215-2023-39632
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729981039
• UDI-Public: 08714729981039
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2023
• Device Lot Number: 0026909858
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Sex: Female