MAUDE Adverse Event Report: ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA) BIOCOR STENTED TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Device Problems Backflow (1064); Obstruction of Flow (2423)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, 56 patients underwent a valve in valve procedure with a portico valve for failed surgical bioprosthesis between january 2016 and june 2019.Six of those patients had a trifecta valve and 7 of those patients had a biocor epic valve implanted prior to the portico valve in valve procedure.Events of aortic regurgitation and stenosis was reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturing reference number: 3008452825-2020-00709.The article, "one-year safety and efficacy profile of transcatheter aortic valve-in-valve implantation with the portico system" was reviewed.The research article is a prospective single center experience to investigate the procedural and mid-term outcomes of transcatheter aortic valve implantation(tavi) for failed surgical bioprosthesis with portico device.Portico(abbott), mitroflow(sorin), trifecta(abbott), magna(edwards lifesciences), aspire(vascutek), biocor epic(abbott), mosaic(medtronic), freedom solo(sorin), freestyle valve(medtronic) and pericarbon freedom(sorin) were associated with the study.There is no allegation of malfunction of the abbott device.The article concluded that tavi-viv with portico valve was associated with good procedural and 1-year outcomes, even in patients with features of high procedural and anatomical complexity.The corresponding author is matteo casenghi, md, clinical and interventional cardiology department, irccs policlinico san donato, san donato milanese, italy with the email matcasengh@hotmail.It.

• Brand Name: BIOCOR STENTED TISSUE VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11068980
• MDR Text Key: 223602635
• Report Number: 3001883144-2020-00129
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 79 YR