MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC TRANSCATHETER DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number MDT-TRANS DCS

Device Problem Insufficient Information (3190)

Patient Problems Fistula (1862); Hematoma (1884); Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226); Stenosis (2263); Cardiac Perforation (2513); Vascular Dissection (3160); Pericardial Effusion (3271)

Event Date 11/01/2021

Event Type  Injury  

Event Description

Medtronic received information from a literature article regarding the use of intravascular lithotripsy to facilitate transfemoral t ranscatheter aortic valve implantation (tavi).All data was collected from multi-center registry between 2018 and 2020.Of the 108 patients included in the study population (predominantly male, mean age 80.5 years), approximately 42 underwent transfemoral tavi with a medtronic evolut r or evolut pro valve system.No unique device identifier numbers were provided.Among all 108 patients in the study population, 3 in-hospital deaths occurred due to failed surgical conversion after annular rupture (n = 1), sepsis (n = 1), and malignant arrhythmia caused by hyperkalemia (n = 1).No statement was made suggesting a causal or contributory relationship between medtronic product and the deaths.Although a direct correlation was not made, the following non-death adverse events mayhave been associated with medtronic transcatheter valves: emergent conversion to open-surgery due to valve embolization into the left ventricular cavity, new permanent pacemaker implantation, and mild to severe aortic regurgitation.Although a direct correlation was not made, the following non-death access-site adverse events may have been associated with medtronic delivery catheter systems: dissection, stenosis, arteriovenous fistula, retroperitoneal hematoma, major bleeding, cardiac structure perforation/injury, pericardial effusion causing cardiac tamponade requiring pericardiocentesis, and need for unplanned endovascular intervention (balloon dilation, covered or bare metal stent implant).No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Citation: nardi g, et al.Peripheral intravascular lithotripsy for transcatheter aortic valve implantation: a multicentre observational study.Eurointervention.2022 apr 1;17(17):e1397-e1406.Doi: 10.4244/eij-d-21-00581.Published online ahead of print november 2021.Earliest date of publish used for date of event: november 1, 2021 (month and year valid).Medtronic products: enveo r delivery catheter system (pma# p130021, product code npt), enveo pro delivery catheter system (pma# p130021, product code npt).Earliest approved product used for product code and pma#.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product, no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MEDTRONIC TRANSCATHETER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14552395
• MDR Text Key: 293351024
• Report Number: 2025587-2022-01520
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MDT-TRANS DCS
• Device Catalogue Number: MDT-TRANS DCS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2022
• 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): Required Intervention; Life Threatening
• Patient Age: 81 YR
• Patient Sex: Male