MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. V.A.C. GRANUFOAM DRESSING; OMP

Model Number VACDSP

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

Patient Problems Wound Dehiscence (1154); Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 09/06/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: the exact date of the event is unknown.The graft was placed and secured with staples on (b)(6) 2021, and no complications were noted.The alleged event took place during a subsequent dressing change.Therefore, (b)(6) 2021, the last date v.A.C.® therapy was in use, was utilized.The v.A.C.® granufoam¿ dressing lot number was not available and the dressing was not returned; therefore, a device history record review and a device evaluation could not be performed.Based on the information provided, it cannot be determined that the alleged dehiscence and subsequent bleeding requiring suturing of the mesh graft are related to the v.A.C.® granufoam¿ dressing and/or its removal.The graft was initially secured with staples and a low-adherent dressing was applied as an interface with the v.A.C.Ulta¿ therapy system at that time.The patient had several dressing changes with no issues.Kci has made multiple unsuccessful attempts to obtain additional clinical and device information.Bleeding: with or without using v.A.C.® 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 anastomoses 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 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 if frank (bright red) blood is seen in the tubing or in the canister, immediately stop v.A.C.® therapy, leave dressing in place, take measures to stop the bleeding and seek immediate medical assistance.The v.A.C.® therapy units and dressings 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.Always ensure the v.A.C.® foam dressings do not come in direct contact with vessels or organs.Use of 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, multiple layers of meshed non-adherent material or bio-engineered tissue 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 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.Patients with deep sternal wounds (i.E.Patients with mediastinitis or sternal wound infection) should have dressing changes supervised or performed by the lead clinician or specialist surgeon, preferably the cardiovascular surgeon.Prior to the application of v.A.C.® therapy to a patient with a deep sternal wound, read and follow the safety information (pages 7-16), specifically the warning regarding bleeding on page 9.For sternal wounds, the lowest negative pressure setting is recommended initially.Monitor closely while progressing to target treatment pressure, as tolerated.For patients with an unstable sternum, continuous therapy is recommended throughout the treatment period to help stabilize the chest wall.This helps pull the wound edges together and provides a "splinting" effect, which may allow the patient to be more mobile and more comfortable.

Event Description

On 21-sep-2021, the following information was provided to kci by the patient: "about three weeks ago, nurse was applying new foam in the wound bed, there were staples in the foam that caused [patient's] wound to have holes and start bleeding.They had to suture the holes with no numbing agent which was very painful.V.A.C.Therapy was on for about three to four dressing changes and then discontinued and [patient] was placed on an alternative dressing.The bleeding was resolved when wound was sutured." on 24-sep-2021, medical records were provided to kci by the healthcare facility which noted the following: on (b)(6) 2021, the patient presented to the hospital with a post-operative sternal wound infection.On (b)(6) 2021, the v.A.C.Ulta¿ therapy system was initially intraoperatively during sternotomy with wound debridement and hardware removal.On (b)(6) 2021 the patient underwent subsequent debridement and flap reconstruction with a split-thickness mesh skin graft that was stapled in place.At that time, the v.A.C.Ulta¿ therapy system was reapplied with a low-adherent non-kci product interface.The surgeon noted no procedural complications.On 24-sep-2021, the following information was provided to kci by the kci representative: during a dressing change, some of the staples used to secure the mesh graft allegedly got caught in the foam which resulted in minor bleeding.The graft remained intact, and the physician sutured the area where staples had been removed.The physician determined sutures would be "better suited" to secure the mesh.The minor bleeding resolved and v.A.C.® therapy continued until discharge on (b)(6) 2021.The v.A.C.® granufoam¿ dressing lot number was not provided, and the product was not returned, therefore a device history record review and device evaluation could not be performed.

• Brand Name: V.A.C. GRANUFOAM DRESSING
• 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: 12652466
• MDR Text Key: 277176032
• Report Number: 3009897021-2021-00249
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VACDSP
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2021
• 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
• Treatment: ATORVASTATIN 80 MG TABLET; CARVEDILOL 6.25 MG TABLET; METFORMAIN HCL ORAL (UNKNOWN DOSAGE); PLAVIX 75 MG TABLET; VICTOZA SUBCUTANEOUS INJECTION
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR