MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. V.A.C.ULTA¿ THERAPY SYSTEM; OMP

Model Number WNDULT

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

Patient Problem Exsanguination (1841)

Event Date 02/28/2024

Event Type  Death  

Manufacturer Narrative

Based on the information provided, it cannot be determined that the patient's death was related to the v.A.C.Ulta¿ therapy system.Multiple unsuccessful attempts were made for additional clinical information.The patient had a complex surgical history complicated by postoperative wound infection.The pre-existing infection and chronic anticoagulant therapy coupled with aggressive debridement predispose the patient to bleeding complications.An elevated inr indicates the patient is at risk of bleeding and abnormal clotting.A device evaluation could not be performed.Device labeling, available in print and online, states: v.A.C.Ulta¿ therapy system contraindications ·do not place foam dressings of the v.A.C.Ulta¿ therapy system (including both v.A.C.® therapy and v.A.C.Veraflo¿ therapy dressings) directly in contact with exposed blood vessels, anastomic sites, organs, or nerves.V.A.C.Ulta¿ therapy system warnings: bleeding: with or without using v.A.C.® therapy or v.A.C.Veraflo¿ therapy, certain patients are at high risk of bleeding complications.The following types of patients are at increased risk of bleeding, which, if uncontrolled, could be potentially fatal.· patients who have weakened or friable blood vessels or organs in or around the wound as a result of, but not limited to: suturing of the blood vessel (native anastomosis or grafts)/organ, infection, trauma, radiation, patients without adequate wound hemostasis, patients who have been administered anticoagulants or platelet aggregation inhibitors, patients who do not have adequate tissue coverage over vascular structures.If v.A.C.® therapy or v.A.C.Veraflo¿ therapy is prescribed for patients who have an increased risk of bleeding complications, they should be treated and monitored in a care setting deemed appropriate by the treating physician.If active bleeding develops suddenly or in large amounts during v.A.C.® therapy or v.A.C.Veraflo¿ therapy, or if frank (bright red) blood is seen in the tubing or in the canister, immediately stop therapy, leave dressing in place, take measures to stop the bleeding and seek immediate medical assistance.The v.A.C.Ulta¿ therapy unit and dressings (both v.A.C.® therapy or v.A.C.Veraflo¿ therapy) should not be used to prevent, minimize or stop vascular bleeding.· protect vessels and organs: all exposed or superficial vessels and organs in or around the wound must be completely covered and protected prior to the administration of v.A.C.® therapy or v.A.C.Veraflo¿ therapy.Always ensure that v.A.C.® foam dressings and v.A.C.Veraflo¿ foam dressings do not come in contact with vessels or organs.Use a thick layer of natural tissue should provide the most effective protection.If a thick layer of natural tissue is not available or is not surgically possible, bio-engineered tissue or multiple layers of non-adherent dressing material may be considered as an alternative, if deemed by the treating physician to provide a complete protective barrier.If using non-adherent materials, ensure they are secured in a manner that will maintain their protective position throughout therapy.Consideration should also be given to the negative pressure setting and therapy mode when used when initiating therapy.Caution should be taken when treating large wounds that may contain hidden vessels which may not be readily apparent.The patient should be closely monitored for bleeding in a care setting deemed appropriate by the treating physician.Disclaimer: this information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a kinetic concepts, inc.Product malfunctioned, is defective or has caused serious injury.

Event Description

On 29-feb-2024, the following information was provided to kci by the facility representative: on 28-feb-2024, the v.A.C.Ulta¿ therapy system allegedly severed the patient's femoral artery resulting in his death.It was reported that the left groin wound allegedly had complete coverage with both soft tissue and 3m¿ adaptic¿ touch dressing to the wound base with the intent to protect the graft site.No additional information was provided.On 25-mar-2024, the following information was obtained and reviewed via (b)(6) medical records: in early january, the patient underwent a left common femoral endarterectomy with runoff.On (b)(6) 2024, staples and sutures were removed; the patient subsequently developed wound dehiscence and drainage and was admitted for further evaluation on (b)(6) 2024.On (b)(6) 2024, the patient underwent an extensive wound washout with surgical muscle flap debridement.Intra-operative wound cultures were positive for staphlyococcus lugdunensis.On (b)(6) 2024, abnormal lab values for hemoglobin (9.1) and hematocrit (28.7) in addition to an elevated inr (2.91) were noted.The nurse did not document the application of a non-adherent dressing to the wound bed prior to placement of the v.A.C.® granufoam¿ dressing.The device was not returned; therefore, a device evaluation could not be performed.

• Brand Name: V.A.C.ULTA¿ THERAPY SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX 78249
• Manufacturer Contact: steven jackson ; 6203 farinon drive; san antonio, TX 78249 ; 2102556438
• MDR Report Key: 18992419
• MDR Text Key: 338810727
• Report Number: 3009897021-2024-00018
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554001244
• UDI-Public: 0100849554001244
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WNDULT
• Device Catalogue Number: 350000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/28/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: COUMADIN TAB 4 MG ORAL DAILY; FLOMAX 0.4 MG ORAL DAILY; INSULIN LISPRO INJECTION 2-7 UNITS SUBCUTANEOUS 4X; LABETALOL INJECTION 10 MG IV Q4H; LIPITOR TAB 80 MG ORAL NIGHTLY; LISINOPRIL TAB 20 MG ORAL Q12H; METOPROLOL SUCCINATE XL 75 MG ORAL Q12H; METOPROLOL TARTRATE INJECTION 2.5 IV Q4H PRN; NARCAN INJECTION 0.4 MG; NORVASC 5 MG TABLET; OXYCODONE 5 MG ORAL Q4H PRN; TYLENOL 650 MG
• Patient Outcome(s): Death
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 97 KG