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

Model Number 10618

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Obstruction/Occlusion (2422)

Event Date 02/11/2023

Event Type  Death  

Event Description

It was reported that an occlusion occurred and the patient died.The patient presented with chronic total occlusion.A 4.00 x 16 synergy and a 3.00 x 48 synergy were implanted in the left main coronary to left anterior descending arteries.During post-dilation of the stent deployed in the left main coronary artery, an occlusion occurred in the left circumflex (lcx).A third stent was deployed from the left main coronary artery to the left circumflex.Post-angioplasty, the patient experienced progressive hypotension subsequent to the lcx occlusion.Although the occlusion opened up immediately during the procedure, the progressive hypotension worsened.An intra-aortic balloon pump was inserted and inotropes were provided, but the hypotension continued to worsen.The patient died two days after the procedure.The official cause of death was progressive hypotension.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16464726
• MDR Text Key: 310487750
• Report Number: 2124215-2023-09691
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2023
• Device Model Number: 10618
• Device Catalogue Number: 10618
• Device Lot Number: 0027641978
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Race: Asian