MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY XD MR US 4.00X20MM; CORONARY DRUG-ELUTING STENT

Model Number SYNERGY XD MR US 4.00X20MM

Device Problem Activation Problem (4042)

Patient Problem Insufficient Information (4580)

Event Date 08/26/2021

Event Type  malfunction  

Event Description

While insufflating the 4.0 20mm stent to deploy, it would not increase more than 5-6 despite multiple attempts and with a new insufflator and 20 cc syringe.The stent was retrieved from the coronary vessel and was deployed into the distal radial artery to avoid embolization.Fda safety report id # (b)(4).

• Brand Name: SYNERGY XD MR US 4.00X20MM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 12421294
• MDR Text Key: 270106940
• Report Number: MW5103695
• Device Sequence Number: 1
• Product Code: NIQ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SYNERGY XD MR US 4.00X20MM
• Device Catalogue Number: H7493941820400
• Device Lot Number: 27351315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR