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

Model Number 10623

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

Patient Problems Ischemia (1942); Vascular Dissection (3160)

Event Date 12/18/2021

Event Type  Injury  

Event Description

It was reported that a dissection occurred.Vascular access was obtained via the radial artery.A percutaneous transluminal coronary angioplasty was performed on a moderately tortuous and moderately calcified left anterior descending artery (lad).A 4.00 x 38 synergy ii drug eluting stent was deployed in the lad.Following deployment, a distal edge dissection was noted in the distal part of the stent.To cover the edge dissection, another 4.00 x 38 synergy was deployed distal to the first stent, overlapping it, and covered the edge dissection.The procedure was successfully completed, and the patient was reported to be stable.

Event Description

It was reported that a dissection occurred.Vascular access was obtained via the radial artery.A percutaneous transluminal coronary angioplasty was performed on a moderately tortuous and moderately calcified left anterior descending artery (lad).A 4.00 x 38 synergy ii drug eluting stent was deployed in the lad.Following deployment, a distal edge dissection was noted in the distal part of the stent.To cover the edge dissection, another 4.00 x 38 synergy was deployed distal to the first stent, overlapping it, and covered the edge dissection.The procedure was successfully completed, and the patient was reported to be stable.It was further reported that the lesion was predilated with a 3x8 semi compliant balloon.The 4x38 synergy stent was deployed at 12 atmospheres for around 4 to 6 seconds.Post dilation was performed with a non compliant balloon at 18 atmospheres, and dissection occurred during post dilation.The dissection was flow limiting.

• Brand Name: SYNERGY
• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13184133
• MDR Text Key: 283490735
• Report Number: 2134265-2021-16529
• 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,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2023
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0026926514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• 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