MAUDE Adverse Event Report: ABBOTT VASCULAR MITRAL CLIP; MITRAL VALVE REPAIR DEVICES

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

Patient Problems Hyperglycemia (1905); Pain (1994); Urinary Tract Infection (2120); Prolapse (2475); Hematuria (2558); Weight Changes (2607); Cancer (3262)

Event Date 03/11/2021

Event Type  Death  

Event Description

I am writing out of concern whether the catheterization practice through the femoral artery, such as to assist in cardiac procedures like the implantation of a mitra heart valve clip, poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcoma, beyond the uterus.In (b)(6) 2021, my 79 year old mother (b)(6), underwent a cardiac procedure for implantation of the mitra clip, which included catheterization through the groin area.Although the procedure was ultimately a success, she claimed there were " two takes" for the procedure.By (b)(6) 2021, she was diagnosed with hematuria, experiencing blood in her urine and urinary tract infection.From (b)(6) to (b)(6) 2022.She had lost 20 pounds and by (b)(6) 2021, was experiencing extreme pain.By (b)(6) 2022, she was diagnosed with endometrial carcinoma and by (b)(6) 2022, she was diagnosed with stage four uterine cancer that had metastasized to her lymph node in her clavicle area.By (b)(6) 2022, she was deceased.Prior to the catheterization of the femoral artery and mitra clip implantation, her cancer was undetected, however she had a diagnosed prolapsed uterus and/or bladder, lab showing increased glucose level, twice her labs showed blood in her urine, and she had been prescribed ketoconazole for groin irritation.My concerns are the following: " whether this procedure, ie femoral artery catheterization, can contribute to cancer spread beyond the uterus " whether medical providers should be required to screen for cancer prior to this procedure "whether medical providers should be required to discuss with patients careful considerations of the benefits and risks to decide if catheterization through the femoral artery is the best option for cardiac surgery in patients with cancer present in female structures "whether health care providers should inform patients that catheterization may spread any cancer, significantly worsening their prognosis.

• Brand Name: MITRAL CLIP
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 16025677
• MDR Text Key: 305992270
• Report Number: MW5113885
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 12/18/2022

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?: No
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2022
• Patient Sequence Number: 1
• Treatment: DIOVAN FOR HYPERTENSION ; KETOCONAZOLE CREME; MACROBID 100MG
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 35 KG