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

Model Number 10620

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

Patient Problems Angina (1710); Ischemia (1942); Vascular Dissection (3160)

Event Date 11/08/2021

Event Type  Injury  

Event Description

It was reported that a dissection occurred.The 90% stenosed target lesion was located in the moderately calcified ostium to mid left anterior descending artery (lad).Following predilatation with a non compliant (nc) balloon, a 4 x 24mm synergy stent was deployed at the target lesion.Following deployment, a distal edge dissection was noted proximal to the first diagonal (d1) of the lad.A 3.50 x 16 synergy stent was advanced to cover the dissected area across d1, but could not cross the previously placed stent at the proximal artery.A 4mm nc balloon was advanced to further dilate the proximal stent.A 3.50 x 16mm stent was advanced, but was not able to cross the lesion.The patient was noted to be symptomatic due to the dissection.Another of same size stent was then advanced, was able to cross the lesion, cover the dissection, and complete the procedure.No further patient complications were reported in relation to this event, and the patient was reported to be stable following the procedure.

Event Description

It was reported that a dissection occurred.The 90% stenosed target lesion was located in the moderately calcified ostium to mid left anterior descending artery (lad).Following predilatation with a non compliant (nc) balloon, a 4 x 24mm synergy stent was deployed at the target lesion.Following deployment, a distal edge dissection was noted proximal to the first diagonal (d1) of the lad.A 3.50 x 16 synergy stent was advanced to cover the dissected area across d1, but could not cross the previously placed stent at the proximal artery.A 4mm nc balloon was advanced to further dilate the proximal stent.A 3.50 x 16mm stent was advanced, but was not able to cross the lesion.The patient was noted to be symptomatic due to the dissection.Another of same size stent was then advanced, was able to cross the lesion, cover the dissection, and complete the procedure.No further patient complications were reported in relation to this event, and the patient was reported to be stable following the procedure.It was further reported that due to the dissection, there was a compromise in distal flow, hence patient developed angina.

• 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 johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12961472
• MDR Text Key: 281925048
• Report Number: 2134265-2021-15580
• 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: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10620
• Device Catalogue Number: 10620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• 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 Age: 85 YR
• Patient Sex: Male
• Patient Weight: 82 KG