|
Catalog Number UNK EPIC STENTED PORCINE HV |
Device Problems
Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915); Central Regurgitation (4068)
|
Patient Problems
Mitral Valve Stenosis (1965); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)
|
Event Date 09/01/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided the additional patient effect of malfunction reported in the article is captured under a separate medwatch report.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
|
|
Event Description
|
The article, "impact of bioprosthetic valve fracture on hemodynamics in transseptal mitral valve-in-valve replacement", was reviewed.The article presented a retrospective, single center study on experiences with bioprosthetic valve fracture (bvf) performed by high-pressure postdilation (hppd) in transcatheter mitral valve-in-valve (mviv).Devices included in this study were sapien 3/3 ultra, sjm biocor/epic, carpentier-edwards perimount/pericardial/magna, and medtronic hancock ii/mosaic.The article concluded that the study demonstrated that bvf following mviv was safe and led to an acute decrease in mean gradient.[the primary and corresponding author was amar krishnaswamy, department of cardiovascular medicine heart, vascular and thoracic institute cleveland clinic, 9500 euclid avenue, j2-3 cleveland, ohio 44195, usa, with corresponding e-mail: krishna2@ccf.Org].
|
|
Manufacturer Narrative
|
Summarized patient outcomes/complications of thv - epic biocor were reported in a research article in a subject population with multiple co-morbidities including stenosis, regurgitation, and ejection fraction.Some of the peri-and post-procedural complications reported were heart failure, hospitalization, stenosis, regurgitation, valve-in-valve (surgical intervention), improper use, and device damaged by another device; these complications are anticipated for the procedure and subject population.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis. based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Per the instructions for use, ifu biocor supra, arten100121084, revision c, it stated, "precaution: do not attempt to repair a valve.Damaged valves must not be used." this is considered as an improper or incorrect procedure or method of the device.However, it was unable to determine if an improper or incorrect procedure or method contributed to the reported incident.Therefore, a letter will not be provided to address the deviation from the ifu.
|
|
Search Alerts/Recalls
|
|
|