MAUDE Adverse Event Report: NUMED, INC. NUDEL; AORTIC STENT DELIVERY SYSTEM

Model Number 423

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rupture (2208); Vascular Dissection (3160)

Event Date 12/18/2018

Event Type  Injury  

Manufacturer Narrative

The report from the hospital stated that there was no definite evidence of device malfunction.A physician stated in an email that "the iliac artery went into spasm and that may have caused the problem." the device was not returned to numed, so "an" a physical examination of the device was not possible.A final qc check is performed on 100% of the devices before they leave numed.A review of the production records show that there were no issues with the devices that were released for distribution.Taken from the nudel ifu: contraindications: patients too small to allow safe delivery of the stent without compromise to the systemic artery used for delivery.Warnings: over-stretching of the artery may result in rupture or aneurysm formation.Do not advance the guidewire, the combined balloon catheter in the sheath, or any other component if resistance is encountered without first determining the cause and taking remedial action.

Event Description

As per the report from the physician / foreign distributor - "life-threatening vascular injury related to attempted transcatheter stenting of aortic coarctation using the nudel system (14f, 4.5cm stent, 18mm balloon).Iliac artery dissection/rupture whilst advancing the 14f sheath.Vessel salvaged using multiple covered stents." "emergency stenting of descending aorta, bilateral iliac arteries.Vascular surgical reconstruction of ilio-femoral artery.Urgent laparostomy for abdominal compartment syndrome.Renal replacement therapy." " no definite evidence of device malfunction.".

• Brand Name: NUDEL
• Type of Device: AORTIC STENT DELIVERY SYSTEM
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• Manufacturer (Section G): NUMED, INC.; 2880 main street; hopkinton NY 12965
• Manufacturer Contact: nichelle laflesh ; 2880 main street; hopkinton, NY 12965 ; 3153284491
• MDR Report Key: 8239284
• MDR Text Key: 132779949
• Report Number: 1318694-2019-00001
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 423
• Device Catalogue Number: DEL025
• Device Lot Number: DEL-0135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2017
• 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 Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 25 YR
• Patient Weight: 59