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

Model Number MCS-P3-31-AOA

Device Problems Perivalvular Leak (1457); Incomplete Coaptation (2507)

Patient Problems Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450); Mitral Valve Insufficiency/ Regurgitation (4451); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 12/29/2020

Event Type  Death  

Manufacturer Narrative

Product analysis: the device remains implanted, therefore no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that nearly seven years following the implant of this transcatheter bioprosthetic valve, the patient experienced worsening lower extremity edema, dyspnea on exertion, and decreased appetite in the setting of medication non-compliance.The patient presented seven years, twenty-eight days following valve implant; an electrocardiogram (ecg) showed a ventricular-paced rhythm and a brain natriuretic peptide (bnp) test revealed an elevated bnp to 1190.A chest x-ray showed interstitial pulmonary edema.The patient was admitted with fluid overload and acute exacerbation of heart failure; diuretic intravenous therapy (iv) was initiated.The following day, upon physical examination, a grade iii/iv systolic murmur was noted.Three days following admission, a transthoracic echocardiogram (tte) was performed and showed a 60% ejection fraction, a mean atrio-ventricular (av) gradient of 14 mm hg, an av peak velocity of 2.5 meters per second, mild mitral regurgitation (mr), mild tricuspid regurgitation (tr), pulmonary hypertension with a right ventricular systolic pressure of 63 mm hg, and moderate anterior paravalvular leak (pvl) with a holodiastolic flow noted in the proximal descending aorta.It was noted that the previous echocardiogram performed two years prior showed trace mr.Four days following admission, the acute exacerbation of heart failure had resolved.A transesophageal echocardiogram (tee) revealed a flail tavr cusp and moderate-to-severe functional tricuspid regurgitation.Per the physician, the worsening pvl contributed to the worsening tr and pulmonary hypertension.No action taken.The patient was discharged with oral diuretic medication in stable condition.Additional information was later received which indicated that approximately seven years and four months following the implant of this valve, worsening shortness of breath and dyspnea at rest was observed.It was noted that the patient was not compliant with the prescribed medication.A tte showed severe central aortic regurgitation.The transvalvular regurgitation originated centrally and took a highly eccentric course within the valve frame.The eccentric course was what raised the suspicion of a leaflet flail.Pvl was unable to be identified based upon the short axis images.Medication management was prescribed.Further, later information was received which indicated that approximately seven years, four months, and twenty-three days following the valve implant, the patient was admitted to hospice care with end-stage heart failure with worsening aortic regurgitation of the transcatheter valve.Transcatheter interventions nor surgical treatments were options for this patient.Subsequently, approximately forty-nine days later, the patient died.As reported, the flail leaflet was the etiology of the patient¿s heart failure which led to death.An autopsy was not performed.

• Brand Name: COREVALVE TRANSCATHETER AORTIC VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11237224
• MDR Text Key: 228903334
• Report Number: 2025587-2021-00285
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/27/2021

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 Expiration Date: 10/15/2013
• Device Model Number: MCS-P3-31-AOA
• Device Catalogue Number: MCS-P3-31-AOA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 01/27/2021
• Date Device Manufactured: 11/08/2012
• 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): Death
• Patient Age: 92 YR
• Patient Weight: 80