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

Lot Number 0028667241

Device Problem Obstruction of Flow (2423)

Patient Problems Cardiac Enzyme Elevation (1838); Vomiting (2144); Thrombosis/Thrombus (4440)

Event Date 03/07/2023

Event Type  Injury  

Event Description

It was reported that thrombosis occurred.The patient presented with acute coronary syndrome for percutaneous coronary angioplasty.The 90% stenosed target lesion was located in the severely calcified proximal to mid left anterior descending artery (lad).Following pre-dilation with multiple balloons, the 2.75 x 20 synergy xd stent was implanted with no issues being reported.Four hours after the procedure, the patient suddenly started vomiting and an electrocardiogram (ekg) confirmed st-segment elevation.An angiographic examination revealed thrombotic occlusion with the 2.75 x 20mm synergy stent.When the thrombus was aspirated, the ekg improved.It was confirmed using intravascular ultrasound (ivus) that nodules derived from calcification were floating in the synergy stent, so an additional synergy was placed in the product.After placement, the floating calcifications disappeared, confirming good apposition.The final angiographic examination confirmed good flow and no perforation, so the procedure was terminated.The patient condition post procedure was stable.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16621307
• MDR Text Key: 312097766
• Report Number: 2124215-2023-14291
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: JA
• 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: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2024
• Device Lot Number: 0028667241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2022
• 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