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

Device Problems Obstruction of Flow (2423); Activation Failure (3270)

Patient Problems Chest Pain (1776); Thrombosis/Thrombus (4440)

Event Date 05/23/2023

Event Type  Injury  

Event Description

It was reported that chest pain, stent thrombosis, insufficient apposition occurred requiring additional intervention.The patient came in for heart catheterization.A 2.75x24 synergy xd stent was implanted in the artery.Later that day, the patient presented with chest pain and acute stent thrombosis was noted.Intravenous ultrasound revealed that the stent was not properly apposed to the vessel wall and under expanded.A subsequent catheterization was performed by another physician to further expanded the stent against the vessel wall and the procedure was completed.No further complications were reported, and the patient has fully recovered.

Event Description

It was reported that chest pain, stent thrombosis, insufficient apposition occurred requiring additional intervention.The patient came in for heart catheterization.A 2.75x24 synergy xd stent was implanted in the artery.Later that day, the patient presented with chest pain and acute stent thrombosis was noted.Intravenous ultrasound revealed that the stent was not properly apposed to the vessel wall and under expanded.A subsequent catheterization was performed by another physician to further expanded the stent against the vessel wall and the procedure was completed.No further complications were reported and the patient has fully recovered.

Manufacturer Narrative

Corrected: h6: patient codes, h6: impact codes, h6: device codes.

• 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: 17181185
• MDR Text Key: 317641222
• Report Number: 2124215-2023-32351
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Male