MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number UNK CDS

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

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 01/01/2022

Event Type  Death  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Dates estimated.The udi number is not known as the part and lot number were not provided.Medwatch report# mw5113885.

Event Description

This is filed to report a patient death.User facility medwatch report received that states: "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.".

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record could not be performed as the lot information regarding the complaint device was not provided.Based on the information reviewed, the reported death appears to be related to stage four uterine cancer which had metastasized to the lymph nodes in the clavicle region and is therefore related to patient conditions.However, due to the limited information available, a cause for the reported hemorrhage (hematuria) and pain cannot be determined.Pain, hemorrhage and death are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Medication required was a result of case-specific circumstances was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.B2, b3: dates estimated d4: the udi number is not known.As the part and lot number were not provided.Medwatch report# mw5113885 attached.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16185882
• MDR Text Key: 307502800
• Report Number: 2135147-2023-00213
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/27/2022
• Initial Date FDA Received: 01/17/2023
• Supplement Dates Manufacturer Received: 02/07/2023
• Supplement Dates FDA Received: 03/01/2023
• 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): Death
• Patient Age: 79 YR
• Patient Sex: Female