MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION COREVALVE REVALVING SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number CRS-P3-943

Device Problem Perivalvular Leak (1457)

Patient Problems Congestive Heart Failure (1783); Death (1802); Endocarditis (1834); Fever (1858); Sepsis (2067); Pseudoaneurysm (2605); No Code Available (3191)

Event Date 09/28/2014

Event Type  Death  

Event Description

Medtronic received information from a journal article that a patient implanted with a transcatheter bioprosthetic heart valve was diagnosed with endocarditis approximately seven months after device implant via transfemoral access.A review of the journal article summary and the original article indicated that the patient presented with acute congestive heart failure and a fever.The patient¿s previous medical history included coronary artery bypass grafting and implantation of another manufacturer¿s prosthetic mitral valve approximately 17 months prior to the aortic valve replacement.The screening on admission before the aortic valve procedure revealed nasal colonization with (b)(6).A decolonization regimen with mupirocin nasal ointment was carried out, and surveillance cultures were (b)(6).Three separate blood cultures were (b)(6).Oscillating intra-cardiac masses could be detected neither on the prosthetic mitral valve nor on the aortic device.However, this device showed a relevant dynamic paravalvular leak that enlarged in diastole, causing deformation of the prosthesis.In addition, diffuse thickening of the aortic root and a discontinuity in the native aortic annulus were present, resulting in the treating physicians¿ diagnosis of an aortic root abscess with a pseudoaneurysm.The patient was treated with antibiotic therapy.The patient expired 18 days later due to sepsis and cardiac decompensation.The patient¿s family refused an autopsy.

Manufacturer Narrative

The date of death was not reported in the article; an arbitrary date of the first of the year of the article's reported year of death is populated here to facilitate electronic submission of the report.Medtronic¿s databases were reviewed in an attempt to determine if these this complaint had previously been reported to medtronic, based on the limited information available; there were no indications that the complaint information had previously been provided to medtronic.It was reported that the device was not explanted.(b)(4).Original article: prosthetic valve endocarditis after transcatheter aortic valve implantation: the incidence in a single-centre cohort and reflections on clinical, echocardiographic and prognostic features authors: miriam puls, md; helmut eiffert, md; mark hünlich, md; friedrich schöndube, md; gerd hasenfuss, md; ralf seipelt, md; wolfgang schillinger, md department of cardiology, georg august university of goettingen, goettingen, germany; department of microbiology, georg august university of goettingen, goettingen, germany; department of cardiovascular surgery, georg august university of goettingen, goettingen, germany.Cited in: transcatheter heart valve failure: a systematic review authors: darren mylotte, ali andalib, pascal the´riault-lauzier, magdalena dorfmeister, mina girgis,waleed alharbi, michael chetrit, christos galatas, samuel mamane, igal sebag, jean buithieu, luc bilodeau, benoit de varennes, kevin lachapelle, ruediger lange, giuseppe martucci, renu virmani, and nicolo piazza european heart journal doi:10.1093/eurheartj/ehu388 september 28, 2014.

Manufacturer Narrative

The reported clinical events in the article are known potential adverse events for bioprosthetic valves (surgical or transcatheter).Without device-identifying information, a review of device history manufacturing and sterilization records could not be performed.A mechanism of failure could not be determined due to the limited amount of information available.

Manufacturer Narrative

Corrected information: no eval explain code.

• Brand Name: COREVALVE REVALVING SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e. deere ave.; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 4381897
• MDR Text Key: 5291363
• Report Number: 2025587-2015-00026
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: CRS-P3-943
• Device Catalogue Number: CRS-P3-943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2015
• Initial Date FDA Received: 01/05/2015
• Supplement Dates Manufacturer Received: Not provided; 07/28/2015
• Supplement Dates FDA Received: 07/31/2015; 09/15/2017
• Was Device Evaluated by Manufacturer?: No
• 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; Hospitalization; Required Intervention
• Patient Age: 00080 YR