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

Model Number 10622

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

Patient Problem Vascular Dissection (3160)

Event Date 03/29/2024

Event Type  Injury  

Event Description

It was reported that a dissection occurred.The 85%-90% stenosed target lesion was located the mildly tortuous and mildly calcified distal left main to proximal left anterior descending artery.A 2.50 x 12 mm non-compliant balloon was used to predilate the lesion.A 3.00 x 12 mm wolverine was then used to further dilate the fibrotic lesion at 12 atm.A 3.00 x 32 mm synergy was deployed at 12 atm and a 3.25 mm non-compliant balloon was used to dilate the lad followed by dilation of the lm with a 4.00 x 8 mm non-compliant balloon.A type b dissection, caused by deployment of the 3.00 x 32 mm synergy, was noted at the proximal part of the stent.A 4.00 x 12 mm synergy was then deployed to cover the dissection.No leakage of contrast was noted and the patient's vitals were stable.The procedure was completed and the patient was safe.

• Brand Name: SYNERGY
• 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: 19083706
• MDR Text Key: 339876204
• Report Number: 2124215-2024-21948
• 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: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10622
• Device Catalogue Number: 10622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 68 KG