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

Model Number WNDINF

Device Problems Unexpected Therapeutic Results (1631); No Apparent Adverse Event (3189)

Patient Problems Wound Dehiscence (1154); Hematoma (1884); Necrosis (1971); Fluid Discharge (2686); Blister (4537); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: the specific date is unknown.The article noted patients included underwent total ankle replacement between jan-2010 and jun-2018.The institution did not use npwt over incisions before 2017.All patients undergoing this surgery after 2017 received npwt.Health effect clinical code: the article defined "wound complications" as wound dehiscence, hematoma, blisters, skin necrosis, and scabbing, abnormal exudation.It is unknown what harm occurred, therefore, all harms were provided.Based on the information available, it cannot be determined what wound complication occurred and if that wound complication was related to the infov.A.C.¿ therapy system.Kci has made multiple unsuccessful attempts to obtain additional clinical and device identification information.The severity of the complication is unknown and kci could not determine if or what medical or surgical intervention was needed.No additional clinical or device identifiers information have been provided.Therefore, a device evaluation and device history review could not be performed.Device labeling, available in print and online, states: if a wound has been progressing well from dressing change to dressing change but then deteriorates rapidly, consider the following interventions and, where necessary, seek the guidance/expertise of a specialist: -check the therapy hour meter to ensure that the actual number of therapy hours received matches the number of recommended therapy hours (22 hours a day).If the number of therapy hours is less than 22 each day, find out why there is a therapy deficit and remedy the situation.Clean wound more thoroughly during dressing changes.Evaluate for signs and symptoms of infection and, if present, treat accordingly.Change dressing often, ensuring that it is being changed at least every 48 hours.Examine the wound and debride as necessary.Debride the wound edges if they appear non-viable or rolled under as this may inhibit the formation of granulation tissue and migration of epithelial cells over an acceptable wound base.Assess for osteomyelitis and, if present, treat accordingly.Clinical considerations:-in case of suspect wound deterioration, the lead clinician should be notified, the wound should be clinically examined, and the plan of care reevaluated.The decision to resume v.A.C.® therapy should be made at the discretion of the lead clinician.

Event Description

On 15-dec-2020, the following information was received by kci after a review of journal article, xi liu, et al.Application of negative pressure wound therapy in total ankle replacement.J foot ankle surg.2020;1-5.Doi.Org/10.1053/j.Jfas.2020.08.021 which noted the following in table 2: one patient in the inpwt [incisional negative wound therapy] group experienced a wound complication.On page 2, under "study design and statistical method" noted, wound complications other than infection that occurred beyond 3 weeks after the operation, such as wound dehiscence, hematoma, blisters, skin necrosis, and scabbing, abnormal exudation were also recorded.On page 4 under "discussion" noted, "in conclusion, the application of inpwt over the total ankle arthroplasty closed incision via anterior approach helps.The patients' quality of life." on 22-dec-2020, the following information was reported to kci by the facility: the devices used in the article are the infov.A.C.¿ therapy system with v.A.C.® granufoam¿ dressing.No additional information was provided.The infov.A.C.¿ therapy system identifier was not provided; therefore, a device evaluation could not be performed.The v.A.C.® granufoam¿ dressing lot number was not provided; therefore, a device history review could not be performed.

Manufacturer Narrative

Based on the additional clinical information provided on 19-jan-2021, kci determined that the alleged wound complication was not related to the infov.A.C.¿ therapy system.The physician confirmed the wound complication was due to the patients' individual characteristics and not due to the infov.A.C.¿ therapy system.Therefore, kci has deemed this event not reportable.

Event Description

On (b)(6) 2021, the following information was reported to kci by the physician: the wound complications were mainly due to the individual characteristics (e.G.Prolonged operative time, excessive swelling, suture response and lipid liquefaction, especially in overweight patients of the patients), instead of negative pressure wound therapy.The physician stated that inpwt [incisional negative wound therapy] helps reduce the risk of such complications because it enhances the wound healing process with less inflammatory response.No additional device information or specific date of occurrence were provided.

• Brand Name: INFOV.A.C. THERAPY SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC; san antonio TX 78249
• MDR Report Key: 11174501
• MDR Text Key: 232588968
• Report Number: 3009897021-2021-00002
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K063740
• 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: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WNDINF
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other