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

Model Number VACDSP

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Abscess (1690); Sepsis (2067)

Event Date 01/01/2007

Event Type  Injury  

Event Description

On (b)(6) 2022, the following information was received by kci after a review of journal article, steenvoorde p., den outer a., neijenhuis p.Stomal mucocutaneous dehiscence as a complication of topical negative pressure used to treat an open abdomen: a case series.Ostomy/wound management 2009;55(6):44-8, which noted the following: the patient, mr.H., a 53-year-old man underwent a laparoscopic resection of the sigmoid to address recurrent diverticulitis.An anastomotic dehiscence occurred, and patient needed repeat surgery.The anastomosis completely failed, requiring creation of a colostomy.Initially, a bogota bag was sutured in the fascia, but management was changed to the tnp [topical negative pressure] dressing system after the patient developed recurrent abscesses in the abdominal cavity that necessitated several surgical drainage procedures.When this problem resolved, new abscesses allegedly developed because the stoma loosened, and fecal material leaked into the abdominal cavity necessitating antibiotic treatment.The patient's condition was stabilized during the icu [intensive care unit] admission and re-suturing.Subsequently, the patient was managed with tnp for 21 days and underwent six or [operating room] dressing changes.A vicryl mesh was sutured on skin level and subsequently received a split-skin graft.Six months later, the patient underwent an abdominal reconstruction, and the colostomy was reversed.The patient underwent eight surgeries during their septic period before split-skin grafting and final abdominal reconstruction with colostomy reversal.The authors reportedly cut the primary drape of the tnp dressing to create two dressing flaps that could be draped around the stoma.The author noted it cannot be determined with certainty that the observed stoma complications were caused by tnp dressing as stoma complications occur regularly, regardless of tnp use.However, this complication was not observed in other patients with colostomies and an open abdomen who were not treated in the icu with tnp and did not occur before provision of tnp, leading the authors to conclude that complications were the result of the tnp dressing, not something related to surgery.No additional information was provided.The abthera¿ open abdomen dressing identifier was not provided and was not returned; therefore, a device history record review and device evaluation could not be performed.

Manufacturer Narrative

Date of event: the specific date of the event was not provided.The time period 2007 was provided in the article, therefore, 01-jan-2007, was utilized.The abthera¿ open abdomen dressing identifier was not provided and was not returned; therefore, a device history record review and a device evaluation could not be performed.Based on the information provided, kci determined that the alleged sepsis was due to use error as the dressing technique used by the author, described as modified tnp, was not placed according to manufacturer's recommendations.This event is being reported due to potential use error.Device labeling, available in print and online, states: warning: review all abthera¿ negative pressure therapy system safety information before beginning wound preparation.Prior to application, please refer to the important safety information for the abthera¿ open abdomen negative pressure therapy system located in appendix 1.Also, for detailed instructions for use, please refer to the abthera¿ open abdomen negative pressure therapy system instructions for use included with each abthera¿ dressing and therapy units.Infection: infected abdominal wounds should be monitored closely and may require more frequent dressing changes than noninfected wounds, dependent upon factors such as patient condition, wound condition and treatment goals.Refer to dressing application instructions for details regarding dressing change frequency (see pages 11-14).

Event Description

The v.A.C.® abdominal dressing identifier was not provided and was not returned; therefore, a device history record review and device evaluation could not be performed.

Manufacturer Narrative

Submitted on 01-jun-2022 noted the following: b5: describe event or problem: the abthera¿ open abdomen dressing identifier was not provided and was not returned; therefore, a device history record review and device evaluation could not be performed.D1: suspect medical device: abthera¿ open abdomen dressing.G4: premarket identification: k090489.H10: additional manufacturer narrative: device labeling, available in print and online, states: warning: review all abthera¿ negative pressure therapy system safety information before beginning wound preparation.Prior to application, please refer to the important safety information for the abthera¿ open abdomen negative pressure therapy system located in appendix 1.Also, for detailed instructions for use, please refer to the abthera¿ open abdomen negative pressure therapy system instructions for use included with each abthera¿ dressing and therapy units.Infection: infected abdominal wounds should be monitored closely and may require more frequent dressing changes than noninfected wounds, dependent upon factors such as patient condition, wound condition and treatment goals.Refer to dressing application instructions for details regarding dressing change frequency (see pages 11-14).Corrections b5: describe event or problem: the v.A.C.® abdominal dressing identifier was not provided and was not returned; therefore, a device history record review and device evaluation could not be performed.D1: suspect medical device: v.A.C.® abdominal dressing g4: premarket identification: k022011 h10: additional manufacturer narrative: device labeling unavailable as device was made obsolete december 2015.Based on the corrections provided, kci's assessment remains the same; it was determined that the alleged sepsis was due to use error as the dressing technique used by the author, described as modified tnp, was not placed according to manufacturer's recommendations.This event is being reported due to potential use error.

• Brand Name: V.A.C.® ABDOMINAL 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: 14569415
• MDR Text Key: 293877438
• Report Number: 3009897021-2022-00094
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K022011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VACDSP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male