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

Lot Number 0029116094

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 09/09/2022

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that acute stent thrombosis occurred.The patient presented with pain, angioplasty was performed and an occluded distal artery was observed.The lesion was pre-dilated; subsequently a synergy megatron mr 3.50 x 20mm stent was advanced and implanted with an optimal final result.The case was completed at 7:26 am.The patient returned the same day at 8:55am with chest pain.Angiography was performed and acute thrombosis was observed within the synergy megatron mr 3.50 x 20mm stent.Balloon angioplasty was performed within the synergy megatron mr 3.50 x 20mm stent with good results.No further patient complications were reported.

• Brand Name: SYNERGY MEGATRON
• 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: 15977582
• MDR Text Key: 305443745
• Report Number: 2124215-2022-37597
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2022

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: 03/10/2024
• Device Lot Number: 0029116094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2022
• 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): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male