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

Model Number EVOLUTPRO-29-US

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

Patient Problems Arrhythmia (1721); Cardiac Enzyme Elevation (1838); Hypoglycemia (1912); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Vomiting (2144); Diaphoresis (2452); Heart Block (4444)

Event Date 11/17/2022

Event Type  Injury  

Manufacturer Narrative

Product analysis: the device remains implanted, therefore no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.Conduction disturbances are known potential adverse effects associated with any cardiac or thoracic procedure (open or catheter-based) and can be resolved with medical treatment or the implant of a permanent pacemaker (with the risk-benefit ratio in favor of implant of the percutaneous aortic valve).A conduction disturbance does not indicate a device malfunction or potential manufacturing issue.Select patient information cannot be included in regulatory report due to regional privacy regulations.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.

Event Description

Medtronic received information that the following the implant of this transcatheter bioprosthetic valve third degree atrio-ventricular block was identified while the patient was in the cardiac care unit (ccu).Intravenous therapy (iv) medication was required.Bradycardia with a rate of 37 beats per minute (bpm) was also identified.A blood gas analysis this day identified a calcium level of 1.06 mmol/l and a potassium of 3.39 mmol/l.Hypocalcemia and hypokalemia were reported.These were reported as possibly related to the procedure.Treatment was not reported for the hypocalcemia.However, iv medication was provided for the hypokalemia.The hypokalemia resolved the following day and the hypocalcemia resolved 5 days later.One day following the valve implant a permanent pacemaker was implanted.This same day the patient experienced palpitations, irritability, sweating, a heart rate of 86 bpm, and a blood pressure of 74/53 millimeters of mercury (mmhg).This was identified as a hypoglycemia episode which required an iv glucose injection and an iv sodium chloride drip.The symptoms were relieved this same date.This was reported as unrelated to the medtronic product and unlikely to the procedure.Also, a myocardial injury occurred.The creatine kinase isoenzyme measured 11.12 ng/ml, the b-type natriuretic peptide precursor measure 1012 ng/l, and the tpn-t measured 126.7 ng/l.This injury was reported as possibly related to the procedure and the valve.Additionally, hypoproteinemia was identified.Albumin measured 38.9 grams per liter (g/l) and total protein 61.4 g/l ten days later.Treatment was not reported.This condition was reported as ongoing and possibly related to the procedure but unrelated to the medtronic products.Nausea and vomiting also occurred after eating.A injection for antiemetic of ondansetron hydrochloride and iv rehydration were required.This condition was considered resolved one day later.This was unlikely related to the procedure or the valve.Additionally on this day, thrombocytopenia was identified with a blood platelet count of ¿96*10^9/l¿.Treatment was not reported, and this condition was considered resolved seven days later.As reported, this was unrelated to the procedure nor to the medtronic products.Nine days following the valve implant procedure, difficulty falling asleep at night occurred.Estazolam tablets were provided, and the issue resolved the following day.This was reported as unrelated to the medtronic products and un likely related to the procedure.No additional adverse patient effects were reported.

Manufacturer Narrative

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.

Event Description

Medtronic received information that the following the implant of this transcatheter bioprosthetic valve third degree atrio-ventricular block was identified while the patient was in the cardiac care unit (ccu).Intravenous therapy (iv) medication was required.Bradycardia with a rate of 37 beats per minute (bpm) was also identified.A blood gas analysis this day identified a calcium level of 1.06 mmol/l and a potassium of 3.39 mmol/l.Hypocalcemia and hypokalemia were reported.These were reported as possibly related to the procedure.Treatment was not reported for the hypocalcemia.However, iv medication was provided for the hypokalemia.The hypokalemia resolved the following day and the hypocalcemia resolved 5 days later.One day following the valve implant a permanent pacemaker was implanted.This same day the patient experienced palpitations, irritability, sweating, a heart rate of 86 bpm, and a blood pressure of 74/53 millimeters of mercury (mmhg).This was identified as a hypoglycemia episode which required an iv glucose injection and an iv sodium chloride drip.The symptoms were relieved this same date.This was reported as unrelated to the medtronic product and unlikely to the procedure.Also, a myocardial injury occurred.The creatine kinase isoenzyme measured 11.12 ng/ml, the b-type natriuretic peptide precursor measure 1012 ng/l, and the tpn-t measured 126.7 ng/l.This injury was reported as possibly related to the procedure and the valve.Additionally, hypoproteinemia was identified.Albumin measured 38.9 grams per liter (g/l) and total protein 61.4 g/l ten days later.Treatment was not reported.This condition was reported as ongoing and possibly related to the procedure but unrelated to the medtronic products.Nausea and vomiting also occurred after eating.A injection for antiemetic of ondansetron hydrochloride and iv rehydration were required.This condition was considered resolved one day later.This was unlikely related to the procedure or the valve.Additionally on this day, thrombocytopenia was identified with a blood platelet count of ¿96*10^9/l¿.Treatment was not reported, and this condition was considered resolved seven days later.As reported, this was unrelated to the procedure nor to the medtronic products.Nine days following the valve implant procedure, difficulty falling asleep at night occurred.Estazolam tablets were provided, and the issue resolved the following day.This was reported as unrelated to the medtronic products and un likely related to the procedure.No additional adverse patient effects were reported.Additional information was received that upon review of the patient¿s medical history the following adverse events reported were not documented at baseline.Hypocalcemia, cause unknown, treated with intravenous medication.The cause of the hypokalemia, hypoglycemia, thrombocytopenia, and hypo-proteinemia was unknown but the patient remained asymptomatic despite the abnormal lab results.Per the physician, the implant procedure may have contributed to the thrombocytopenia.A myocardial injury which presented in elevated rel ated lab values was considered related to the cardiac surgery; however, it was confirmed a myocardial infarction had not occurred and there were no associated symptoms.No additional adverse patient effects were reported.

Event Description

Additional information received indicated that the skin pain could have been edema from heart disease.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: EVOLUT PRO TRANSCATHETER AORTIC VALVE
• 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: 16040691
• MDR Text Key: 306061096
• Report Number: 2025587-2022-03698
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000017835
• UDI-Public: 00763000017835
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2023
• Device Model Number: EVOLUTPRO-29-US
• Device Catalogue Number: EVOLUTPRO-29-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2022
• Date Device Manufactured: 03/07/2021
• 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
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 55 KG