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

Lot Number 0030247309

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Heart Problem (4454)

Event Date 12/04/2023

Event Type  Death  

Event Description

It was reported that the patient died.The patient presented with co-morbidities of extremely calcified vessels.The lesion being treated was the left anterior descending (lad) artery.An opticross intravascular ultrasound (ivus) imaging was utilized to ensure the correct sizing and strategy in approaching treatment of the lesion.Following orbital atherectomy to prepare the severely calcified vessel, ivus imaging was performed followed by a 10mm x 2.5mm wolverine cutting balloon catheter to further prepare the vessel prior stenting the lad.A 3.00 x 24mm and a 2.50 x 28mm synergy xd drug-eluting stents were deployed in the proximal and mid lad successfully.Post-dilatation was then performed using a 3.00mm x 15mm and a 2.50mm x 12mm nc emerge balloon catheters.After a second run of ivus imaging and confirmation of stent expansion, the procedure was deemed successfully completed.After the procedure, the patient status was initially good, and the patient was taken back to the recovery ward.However, 15 minutes later, the patient's health declined and was brought back to the procedure room to investigate the cause.An attempt to re-wire the original lesion was unsuccessful as the patient health continued to decline.The patient crashed and cardiopulmonary resuscitation (cpr) was performed, however unsuccessful, and the patient passed away.The official cause of death was post-procedural complication.

• 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: 18387773
• MDR Text Key: 331265082
• Report Number: 2124215-2023-69614
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 0030247309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• 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 Sex: Female