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 R52

Device Problem Material Deformation (2976)

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

Event Date 10/25/2023

Event Type  malfunction  

Event Description

Reportedly, the vega 52 s/n (b)(6) was used in the right atrial appendage.The physician encountered difficulties to insert the butterfly tool on the connector pin (tool used to extend the screw) and it was suspected that the physician has used the butterfly of another lead (ventricle lead) which is not compatible with the vega 52 lead to extend the screw and to position the vega 52 lead in the atrium.It was noticed that the connector pin of the vega 52 lead was bent.The sales rep present in the or advised for a new lead and the physician agreed.A new vega r52 lead was implanted into the right atrial appendage with no issues.

Event Description

Reportedly, the vega 52 s/n: (b)(6)was used in the right atrial appendage.The physician encountered difficulties to insert the butterfly tool on the connector pin (tool used to extend the screw) and it was suspected that the physician has used the butterfly of another lead (ventricle lead) which is not compatible with the vega 52 lead to extend the screw and to position the vega 52 lead in the atrium.It was noticed that the connector pin of the vega 52 lead was bent.The sales rep present in the or advised for a new lead and the physician agreed.A new vega r52 lead was implanted into the right atrial appendage with no issues.

Manufacturer Narrative

Summary of investigation: upon reception of the returned product, visual inspection confirmed the reported bending of the connector pin.The manufacturing process of the lead was re-investigated, and all production steps and tests had been performed according to all applicable procedures.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 of the ventricular lead (different model) which is not compatible with the vega lead was connected at the implant attempt to the vega r52, s/n: (b)(6) connector pin.It should be noted that such bending could also occur if an excessive load is applied when connecting disconnecting the butterfly tool to/from the connector pin.The physician¿s manual provides the following indication to attach the butterfly tool to the connector pin.For more details, please refer to the attached report analysis.

• 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
• MDR Report Key: 18192610
• MDR Text Key: 328811055
• Report Number: 1000165971-2023-00959
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P130010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VEGA R52
• Device Catalogue Number: TLD041C
• 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: 11/28/2023
• 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