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

Model Number VEGA R58

Device Problem Material Deformation (2976)

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

Event Date 08/31/2023

Event Type  malfunction  

Event Description

Reportedly, the connector pin broke during implantation.

Manufacturer Narrative

Investigation summary: the manufacturing process of the lead was re-investigated, and all production steps and tests had been performed according to all applicable procedures.Upon reception of the returned lead, visual inspection confirmed the reported bending of the connector pin.No other anomalies were observed.Visual inspection revealed the presence of the welding points on the lead connector, which confirmed that it was correctly fixed to the lead.Based on the quality controls in place to prevent the distribution of products with such damage, and considering the bending was not observed during the final visual inspection of the packaging nor by taking the lead.It is suspected that the connector pin was inadvertently damaged when the butterfly tool was connected to the connector, either by incorrect placement or by a sudden movement.It should be noted that such a bending could occur if an excessive load is applied when connecting the butterfly tool to the connector pin.The physician¿s manual provides the following indication to attach the butterfly tool to the connector pin.

Event Description

Reportedly, the connector pin broke during implantation.

• Brand Name: VEGA
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Manufacturer (Section D): MICROPORT CRM S.R.L.; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• Manufacturer (Section G): MICROPORT CRM S.R.L.; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• Manufacturer Contact: elodie vincent ; via crescentino s.n; saluggia (vc) 13040 ; IT 13040 ; 146013665
• MDR Report Key: 17772044
• MDR Text Key: 323684766
• Report Number: 1000165971-2023-00733
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P130010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 Ethnicity: Non Hispanic