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

Model Number 10622

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 05/11/2020

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that shaft break occurred.Vascular access was obtained via the right radial artery.The 25% stenosed, eccentric target lesion was an area of restenosis with a significant bend located in the left anterior descending artery (lad).Pre-intervention intravascular ultrasound (ivus) revealed fibrous and fibro lipid plaque in the lad and first diagonal artery (dg1).A percutaneous coronary intervention was performed with a 3.00 x 32 synergy drug-eluting stent (des) in the mid lad.However, it was noted that shaft was fractured for des in the mid lad.The fractured shaft was successfully removed by balloon trapping technique within the guide extension catheter.The bifurcation of the lad and dg1 was treated using a 4.00 x 20mm synergy des and in the proximal lad and a 2.50 x 12mm synergy des in the dg to complete the procedure.Post-intervention ivus revealed normal stent expansion with no malapposition and no edge stent dissection.No patient complications were reported and the patient was stable.

• 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: 10119264
• MDR Text Key: 194014718
• Report Number: 2134265-2020-06658
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Model Number: 10622
• Device Catalogue Number: 10622
• Device Lot Number: 0023460338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2019
• 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
• Treatment: GUIDE CATHETER: EBU3.5; GUIDE CATHETER: JR4.00
• Patient Outcome(s): Other