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

Model Number MDT-TRANS DCS

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Intimal Dissection (1333); Aortic Valve Stenosis (1717); Hematoma (1884); Unspecified Infection (1930); Vascular System (Circulation), Impaired (2572); Blood Loss (2597); Pseudoaneurysm (2605)

Event Date 06/26/2020

Event Type  Injury  

Manufacturer Narrative

Citation: ruge et al.Access site related vascular complications with third generation transcatheter heart valve systems.Catheter cardiovasc interv.2020 jun 26.Doi: 10.1002/ccd.29095.E-published: 26 june 2020.Earliest date of publish used for event date in medtronic products referenced: enveo and 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.

Event Description

Medtronic received information via literature regarding access-site related vascular complications with third generation transcatheter heart valve systems.All data were collected from a single center between march 2014 and april 2019.The study population included 878 patients (predominantly male, mean age 80 years, 75 kg), 459 of whom were implanted with medtronic evolut r (n=418) and evolut pro (n=41) bioprosthetic valves (no serial numbers provided) and delivered by way of the enveo or enveo pro delivery catheter system (dcs).Among all patients, seven in-hospital deaths occurred.The authors stated that patients with a vascular complication had an increased intra-hospital mortality compared to patients who did not.No further details were provided on the deaths.Based on the available information medtronic product was not directly associated with the death(s).Among all patients there were 152 vascular complications.Detailed adverse events included: access-site bleeding, intraprocedural bleeding, post-procedural hematoma, vessel dissection, vessel stenosis/occlusion, false aneurysm, and wound infection.Treatments included blood transfusions, compression, intervention and extended hospital stays.Based on the available information medtronic product may have been associated with the adverse event(s).No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Correction to coding in h6.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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 DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 10352915
• MDR Text Key: 208977066
• Report Number: 2025587-2020-02480
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: 07/08/2020
• Supplement Dates FDA Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 75