MAUDE Adverse Event Report: NUMED, INC. NUCLEUS AORTIC 20 MM; BALLOON AORTIC VALVULOPLASTY

Catalog Number PVN230

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

Patient Problems Tachycardia (2095); Dizziness (2194); Rupture (2208); Heart Block (4444); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Medtronic received information that following implant of this transcatheter bioprosthetic core valve there was moderate aortic regurgitation (ar).A balloon valvuloplasty was performed utilizing a non-medtronic balloon (numed canada inc.Nucleus aortic 20 mm reference number: pvn230 lot: y-3357), however post-valvuloplasty a ventricular septal rupture was documented on transesophageal echocardiogram (tee).The patient was intubated and a second core valve was successfully implanted which rectified the ar from moderate to mild.The ventricular septal rupture had subsequently reduced in size with no further sign of bleeding.Post-procedure (same day) the patient developed a left bundle branch block (lbbb).One day post-implant, complete heart block (chb) was noted when the patient temporary pacing rate was slowed.Also noted was occasional runs of non-sustained ventricular tachycardia, this caused some dizziness and palpitations which was treated with medication.The patient had a pacemaker successfully implanted six days post? implant due to the chb.No additional adverse patient effects were reported.(b)(4) this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: NUCLEUS AORTIC 20 MM
• Type of Device: BALLOON AORTIC VALVULOPLASTY
• Manufacturer (Section D): NUMED, INC.
• MDR Report Key: 17523741
• MDR Text Key: 321150965
• Report Number: MW5130688
• Device Sequence Number: 1
• Product Code: OZT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/09/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Catalogue Number: PVN230
• Device Lot Number: Y-3357
• Patient Sequence Number: 1