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

Model Number 10619

Device Problem Defective Device (2588)

Patient Problem Vascular Dissection (3160)

Event Date 06/28/2022

Event Type  Injury  

Event Description

It was reported that a dissection occurred.The patient presented with chest pain for percutaneous transluminal coronary angioplasty.The target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.50 x 20 synergy stent was implanted but after it was deployed it was noted that the stent failed to cover the full lesion proximally and there was a non-flow limiting mild dissection proximal to the stent.A 2.75 x 32 synergy stent was implanted overlapping the first stent, and covering the missed lesion and dissection.The patient was doing well.

Manufacturer Narrative

Initial reporter address 1: (b)(4).

Manufacturer Narrative

E1: initial reporter address 1: (b)(6).

Event Description

It was reported that a dissection occurred.The patient presented with chest pain for percutaneous transluminal coronary angioplasty.The target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.50 x 20 synergy stent was implanted but after it was deployed it was noted that the stent failed to cover the full lesion proximally and there was a non-flow limiting mild dissection proximal to the stent.A 2.75 x 32 synergy stent was implanted overlapping the first stent, and covering the missed lesion and dissection.The patient was doing well.It was further reported that the stent was found to be shorter than the lesion.It was noted that the initially assessed that the 2.50 x 20 synergy stent would cover the 18-20mm lesion, but after deployment, the stent was noted to be a little shorter than the lesion and mild proximal stent dissection was observed.A 2.75 x 32 synergy stent was deployed to cover the rest of the missed lesion and dissection, proximally.Intravascular ultrasound (ivus) was not performed.No further patient complications were reported in relation to this event.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15047676
• MDR Text Key: 296124243
• Report Number: 2124215-2022-26190
• 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: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2024
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0028741670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2022
• 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
• Patient Race: Asian