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

Device Problem Obstruction of Flow (2423)

Patient Problems Chest Pain (1776); Non specific EKG/ECG Changes (1817); Thrombosis/Thrombus (4440)

Event Date 11/28/2022

Event Type  Injury  

Event Description

It was reported that thrombus occurred.A 2.75x38mm and 2.75x16mm synergy xd balloon expandable stents were implanted in the proximal mid left anterior descending (lad) artery.The stents were posy dilated with a nc emerge 3.0x15mm balloon catheter.The patient was given up to 14,000 units of heparin during the initial implant procedure but could not achieve and act over 250.The stent implants went well.After 1 hour in the post procedural recovery area, the patient began to have severe chest pain and show st elevations in the ekg.The patient was returned immediately to the cath lab procedure room and was found to have occluded lad artery with thrombus.An additional 10,000 units of heparin was administered, and the patient act was drawn and was found to be therapeutic at 408.A larger post-dilatation balloon of 4.0x12 mm and expanded the stents once more.Timi iii flow was achieved, and the chest pain and ekg changes were resolved.The patient was then placed on aggrastat for a few hours and was transferred to another hospital where the patient was observed for 48 hours, and patient was discharged.The patient is expected to make a full recovery with no lasting damage from this incident.

Event Description

It was reported that thrombus occurred.A 2.75x38mm and 2.75x16mm synergy xd balloon expandable stents were implanted in the proximal mid left anterior descending (lad) artery.The stents were post dilated with a nc emerge 3.0x15mm balloon catheter.The patient was given up to 14,000 units of heparin during the initial implant procedure but could not achieve and act over 250.The stent implants went well.After 1 hour in the post procedural recovery area, the patient began to have severe chest pain and show st elevations in the ekg.The patient was returned immediately to the cath lab procedure room and was found to have occluded lad artery with thrombus.An additional 10,000 units of heparin was administered, and the patient act was drawn and was found to be therapeutic at 408.A larger post-dilatation balloon of 4.0x12 mm and expanded the stents once more.Timi iii flow was achieved, and the chest pain and ekg changes were resolved.The patient was then placed on aggrastat for a few hours and was transferred to another hospital where the patient was observed for 48 hours, and patient was discharged.The patient is expected to make a full recovery with no lasting damage from this incident.It was further reported that the lesion was 80% stenosed with mild calcium and not tortuous.

• Brand Name: SYNERGY XD
• 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: 15928383
• MDR Text Key: 304954620
• Report Number: 2124215-2022-51077
• 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: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2022
• 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; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male