MAUDE Adverse Event Report: NUMED, INC. 10 ZIG 8.4 CM G-ARMOR STENT; AORTIC STENT

Lot Number EER-8881

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/14/2022

Event Type  malfunction  

Event Description

During the procedure (fistula repair), the stent covering dislodged, and the provider was unable to recover the product.The insert site was the groin, and the deployment site was intended to be the pulmonary artery.

• Brand Name: 10 ZIG 8.4 CM G-ARMOR STENT
• Type of Device: AORTIC STENT
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 16121246
• MDR Text Key: 306901223
• Report Number: 16121246
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/27/2022

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 Lot Number: EER-8881
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22995 DA
• Patient Sex: Male
• Patient Weight: 117 KG