MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Device Problem Perivalvular Leak (1457)

Patient Problems Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

The article, "plaster pipes and crystalized graphite: open transventricular transcatheter aortic valve replacement for failed mechanical aortic valve prostheses in the porcelain aorta", was reviewed.This research article presented a case study on a (b)(6)-year-old male with a 270 degree dehisced hypermobile 20-year-old sjm pyrolytic carbon mechanical-savr with torrentially severe paravalvular regurgitation with nyha iv congestive cardiac failure.The patient also had concomitant new severe left main coronary artery (lmca) disease with a left dominant coronary system with no previous revascularization procedures.The patient had a severely and diffusely calcified porcelain aorta owing to prior mantle thoracic radiation therapy (xrt) for lymphoma.The aortic root, ascending aorta and transverse aorta all had significant contiguous areas of circumferential calcification.It was deemed by heart team consensus that conventional re-do savr would be technically unachievable and be of prohibitive risk because of the extent of calcification, extending from the aortic annulus to the distal aortic arch.The presence of a mechanical-savr prosthesis also meant standard retrograde valve-in-valve transcatheter aortic valve replacement (tavr) was not possible.However, a novel hybrid procedure was conceived, and embarked upon given the alternative course.A re-do midline-sternotomy, left internal thoracic artery (lita) and left radial artery (lra) harvest was performed and the aforementioned mechanical-savr prosthesis was removed through a left ventriculotomy that was accessed via the mid-line sternotomy and a sapien 3(edwards lifesciences) valve was implanted.At 90-days the patient was nyha functional class i and had returned to work.The article concluded that using a hybrid of an open trans-ventricular approach, integrated with transcatheter and tavr techniques, a novel procedural solution for patients with a failed mechanical-savr prosthesis and an inoperable porcelain aorta has been identified.The primary author of the article is matthew s.Yong mbbs, 1 department of cardiothoracic surgery, princess alexandra hospital, ipswich road, brisbane, australia.The correspondence author is christopher m.Cole, ba, mbbs, fracs, department of cardiothoracic surgery, princess alexandra hospital, ipswich road, brisbane, queensland, australia with the corresponding email: christopher.Cole@health.Qld.Gov.Au.

Manufacturer Narrative

As reported in a research article, a patient with a 20 year old sjm mechanical heart valve and severely calcified porcelain aorta underwent redo surgical aortic valve replacement; an event of heart failure, paravalvular leak, and device explant 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.

• Brand Name: SJM MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 11579721
• MDR Text Key: 242678207
• Report Number: 2648612-2021-00024
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR