MAUDE Adverse Event Report: ST. JUDE MEDICAL, BRASIL LTDA EPIC SUPRA VALVE W/FLEXFIT; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number ESP100-27

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Pseudoaneurysm (2605); Weight Changes (2607)

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, "transradial closure of a large ascending aortic pseudoaneurysm with a duct occluder" was reviewed.This research article presents a case study on a (b)(6) year old male who was admitted to the hospital with a history of coronary artery bypass grafting (cabg) with left internal mammary artery(lima) to the intermediate artery and left radial artery to the posterior descending artery(pda) 6 years previously.Concomitantly, the patient had undergone aortic valve replacement with a 27mm epic supra bioprosthetic valve.The patient presented with complaints of shortness of breathwith exertion.Contrast computed tomography(ct) of the chest showed a retrosternally located large pseudoaneurysm(pa )of the ascending aorta (84 mm × 45 mm × 58 mm) with a diameter of the neck measuring 4 mm.Because of the high mortality and morbidity associated with re-operation, the multidisciplinary heart team decided to take an interventional approach to close the pa.A 6/4 mm amplatzer duct occluder ii was then carefully inserted into the non-abbott guiding catheter after being preloaded on the delivery cable.The distal disc was expanded in the aneurysm cavity, and both catheter and delivery cable were pulled back in order to fix the distal disc to the outer wall of the aorta.The proximal disc was then deployed and pushed against the inner aortic wall.Transthoracic echocardiography confirmed the correct position of the two discs on the inner and 0uter wall of the aorta with no evidence of residual shunting.The occluder device was successfully released and the patient was discharged the next day.The article concluded that the transradial approach should be considered in patients presenting with pas with a relatively small neck and suitable anatomy.The primary and corresponding author of the article is maren weferling, kerckhoff heart and thorax center, department of cardiology, bad nauheim, germany with the corresponding email:(b)(6).

Manufacturer Narrative

As reported in a research article, a pseudoaneurysm of the ascending aorta was found 6 years after device implant.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: EPIC SUPRA VALVE W/FLEXFIT
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 11979920
• MDR Text Key: 267463899
• Report Number: 3001883144-2021-00084
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P040021
• 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: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESP100-27
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR