MAUDE Adverse Event Report: MICROPORT CRM S.R.L. VEGA; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA)

Model Number VEGA R58

Device Problems Difficult to Insert (1316); Material Deformation (2976); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2023

Event Type  malfunction  

Event Description

The physician reported that during insertion in the introducer the lead had a lot of friction and couldn¿t slide properly.He observed an abnormal wrinkled lead body.Technical analysis is required.

Event Description

Reportedly, the physician reported that during insertion in the introducer the lead had a lot of friction and couldn't slide properly.He observed an abnormal wrinkled lead body.

Manufacturer Narrative

Correction action : b3 :date of event.

Event Description

Reportedly, the physician reported that during insertion in the introducer the lead had a lot of friction and couldn't slide properly.He observed an abnormal wrinkled lead body.

• Brand Name: VEGA
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA)
• Manufacturer (Section D): MICROPORT CRM S.R.L.; via crescentino s.n; saluggia, 13040 ; IT 13040
• Manufacturer (Section G): MICROPORT CRM S.R.L.; via crescentino s.n; saluggia, 13040 ; IT 13040
• Manufacturer Contact: elodie vincent ; via crescentino s.n; saluggia, 13040 ; IT 13040
• MDR Report Key: 17161703
• MDR Text Key: 317947539
• Report Number: 1000165971-2023-00460
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P130010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VEGA R58
• Device Catalogue Number: VEGA R58
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic