V.A.C.ULTA THERAPY SYSTEM

Report

Report Number: 3009897021-2021-00163
Event Type: Injury
Date Received: July 23, 2021
Date of Event: January 1, 2019
Report Date: August 13, 2021
Manufacturer: KINETIC CONCEPTS, INC.
Product Code: OMP
PMA / PMN Number: K162790
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SN
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

MDR-3009897021-2021-00163 SUBMITTED ON (B)(6) 2021 NOTED THE FOLLOWING: SECTION G4 PREMARKET IDENTIFICATION: PMA/510(K): WAS BLANK AND DEVICE BLA: K162790. CORRECTION: SECTION G4 PREMARKET IDENTIFICATION: PMA/510(K): K162790 AND DEVICE BLA: N/A. BASED ON THE ADDITIONAL INFORMATION OBTAINED FROM THE CO-AUTHOR, KCI'S ASSESSMENT REMAINS THE SAME; IT CANNOT BE DETERMINED THAT THE ALLEGED EVENTS ARE RELATED TO THEM V.A.C.ULTA¿ THERAPY SYSTEM. PER THE CO-AUTHOR AND DIRECTOR OF VASCULAR SURGERY, THE CAUSE OF THE DESICCATION AND ADJACENT TOE INJURY IS INDETERMINATE AND THE RELATIONSHIP TO NPWTI-D IS UNKNOWN. THE PURPOSE OF THE ARTICLE WAS NOT TO IDENTIFY THE CAUSE OF THE PHENOMENON BUT TO PRESENT A TECHNIQUE THAT MITIGATES IT, MADE POSSIBLE BY THE USE OF V.A.C. VERAFLO CLEANSE CHOICE¿ DRESSING. THE PHENOMENON IS COMMON AND PAR FOR THE COURSE OF CARE FOR PATIENTS WHO HAVE VASCULOPATHY, MOST OF WHOM HAVE DIFFICULT TO TREAT WOUNDS AFTER RESECTION OF INFECTED GANGRENE AND / OR OSTEOMYELITIS.

Description of Event or Problem · 0

ON (B)(6) 2021, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE CO-AUTHOR/DIRECTOR OF VASCULAR SURGERY: THE FIVE PATIENTS THAT EXHIBITED DESICCATION UNDERWENT "AMPUTATION OF THE ADJACENT DIGIT AS THE DONOR TOE AFTER NPWT". THE CAUSE OF THE DESICCATION AND ADJACENT TOE INJURIES ARE INDETERMINATE AND THE RELATIONSHIP TO NPWTI-D IS UNKNOWN. THE PURPOSE OF THE ARTICLE WAS NOT TO IDENTIFY THE CAUSE OF THE PHENOMENON BUT TO PRESENT A TECHNIQUE THAT MITIGATES IT, MADE POSSIBLE BY THE USE OF V.A.C. VERAFLO CLEANSE CHOICE¿ DRESSING. THE PHENOMENON IS COMMON AND PAR FOR THE COURSE OF CARE FOR PATIENTS WHO HAVE VASCULOPATHY, MOST OF WHOM HAVE DIFFICULT TO TREAT WOUNDS AFTER RESECTION OF INFECTED GANGRENE AND / OR OSTEOMYELITIS. THE DEVICE IDENTIFIERS WERE NOT RECORDED. AS THIS WAS A RETROSPECTIVE REVIEW, THE V.A.C. VERAFLO CLEANSE CHOICE¿ DRESSINGS WERE DISCARDED AND EVALUATIONS COULD NOT BE PERFORMED. ADDITIONALLY, THE FIVE V.A.C.ULTA¿ THERAPY SYSTEM IDENTIFIERS WERE NOT RECORDED; THEREFORE, THE ASSOCIATED SERVICE RECORDS COULD NOT BE REVIEWED.

Additional Manufacturer Narrative · 1

THE SPECIFIC AGES AND DATE OF BIRTHS WERE NOT PROVIDED. THE ARTICLE NOTED THE PATIENT AGE RANGE AS 41-81 YEARS WITH A MEAN AGE OF 58 YEARS. THE ARTICLE NOTED THAT THERE WERE 7 MALES AND 2 FEMALES INCLUDED IN THE STUDY. THE SPECIFIC DATES OF THE EVENTS WERE NOT PROVIDED. THE ARTICLE NOTED PATIENTS WERE INCLUDED IN THE STUDY BETWEEN 01-JAN-2019 THROUGH 31-DEC-2020. OTHER DEVICE IDENTIFIERS WERE NOT PROVIDED AND THE DEVICES WERE NOT RETURNED. BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED EVENTS WERE RELATED TO THE V.A.C.ULTA¿ THERAPY SYSTEM. THE ARTICLE NOTED THAT 6 OUT OF 9 PATIENTS DID NOT HAVE VIABLE MEDIAL SIDED SKIN ON THE AFFECTED DIGIT NECESSARY FOR THE TURNED-DOWN ONTO PERICAPSULAR-TISSUE HEMISECTIONED AMPUTATED TOE (TOPHAT) FLAP PROCEDURE AT THE TIME OF THE PRIMARY AMPUTATION, AND DESPITE TREATMENT WITH NPWTI-D [NEGATIVE PRESSURE WOUND THERAPY WITH INSTILLATION AND DWELL-TIME], THE TISSUE IN THE REGION OF THE THIRD METATARSAL HEAD REMAINED UNHEALTHY WITH EVENTUAL DESICCATION AND EXPOSURE OF THE CAPSULE. WOUND HEALING WAS IMPEDED BY ACTIVE INFECTION, PERIPHERAL VASULAR DISEASE, AND DIABETES MELLITUS TYPE II. IT IS UNCLEAR IF AND WHAT MEDICAL AND OR/SURGICAL INTERVENTION TO RESOLVE THE ALLEGED TISSUE DESICCATION WAS NECESSARY. KCI HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITINAL CLINICAL AND DEVICE INFORMATION. KCI HAS NOT BEEN ABLE TO OBTAIN SUFFICIENT INFORMATION TO ESTABLISH A ROOT CAUSE. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: V.A.C. ULTA¿ THERAPY SYSTEM WARNINGS. INFECTED WOUNDS: INFECTED WOUNDS SHOULD BE MONITORED CLOSELY AND MAY REQUIRE MORE FREQUENT DRESSING CHANGES THAN NONINFECTED WOUNDS, DEPENDENT UPON FACTORS SUCH AS WOUND CONDITIONS, TREATMENT GOALS, AND V.A.C. VERAFLO¿ THERAPY PARAMETERS (FOR THE V.A.C. ULTA¿ THERAPY SYSTEM). REFER TO DRESSING APPLICATION INSTRUCTIONS (FOUND IN V.A.C.® DRESSING AND V.A.C. VERAFLO¿ THERAPY DRESSING CARTONS) FOR DETAILS REGARDING DRESSING CHANGE FREQUENCY. AS WITH ANY WOUND TREATMENT, CLINICIANS AND PATIENTS/CAREGIVERS SHOULD FREQUENTLY MONITOR THE PATIENT'S WOUND, PERIWOUND TISSUE AND EXUDATE FOR SIGNS OF INFECTION, WORSENING INFECTION, OR OTHER COMPLICATION. SOME SIGNS OF INFECTION ARE FEVER, TENDERNESS, REDNESS, SWELLING, ITCHING, RASH, INCREASED WARMTH IN THE WOUND OR PERIWOUND AREA, PURULENT DISCHARGE, OR STRONG ODOR. INFECTION CAN BE SERIOUS, AND CAN LEAD TO COMPLICATIONS SUCH AS PAIN, DISCOMFORT, FEVER, GANGRENE, TOXIC SHOCK, SEPTIC SHOCK AND/ OR FATAL INJURY. SOME SIGNS OR COMPLICATIONS OF SYSTEMIC INFECTION ARE NAUSEA, VOMITING, DIARRHEA, HEADACHE, DIZZINESS, FAINTING, SORE THROAT WITH SWELLING OF THE MUCUS MEMBRANES, DISORIENTATION, HIGH FEVER, REFRACTORY AND/ORTHOSTATIC HYPOTENSION, OR ERYTHRODERMA (A SUNBURN-LIKE RASH). IF THERE ARE ANY SIGNS OF THE ONSET OF SYSTEMIC INFECTION OR ADVANCING INFECTION AT THE WOUND SITE, CONTACT A PHYSICIAN IMMEDIATELY TO DETERMINE IF V.A.C.® THERAPY OR V.A.C. VERAFLO¿ THERAPY SHOULD BE DISCONTINUED. PROTECT TENDONS, LIGAMENTS AND NERVES: TENDONS, LIGAMENTS AND NERVES SHOULD BE PROTECTED TO AVOID DIRECT CONTACT WITH V.A.C.® FOAM DRESSINGS OR V.A.C. VERAFLO¿ THERAPY FOAM DRESSINGS. THESE STRUCTURES MAY BE COVERED WITH NATURAL TISSUE OR MESHED NON-ADHERENT MATERIAL TO HELP MINIMIZE RISK OF DESICCATION OR INJURY. V.A.C. ULTA¿ THERAPY SYSTEM PRECAUTIONS. PROTECT PERIWOUND SKIN: CONSIDER USE OF A SKIN PREPARATION PRODUCT TO PROTECT PERIWOUND SKIN. DO NOT ALLOW FOAM TO OVERLAP ONTO INTACT SKIN. PROTECT FRAGILE/FRIABLE PERIWOUND SKIN WITH ADDITIONAL V.A.C.® DRAPE, SKIN PROTECTANT, HYDROCOLLOID, OR OTHER TRANSPARENT FILM. MULTIPLE LAYERS OF THE V.A.C.® DRAPE MAY DECREASE THE MOISTURE VAPOR TRANSMISSION RATE, WHICH MAY INCREASE THE RISK OF MACERATION. IF ANY SIGNS OF IRRITATION OR SENSITIVITY TO THE DRAPE, FOAM, OR TUBING ASSEMBLY APPEAR, DISCONTINUE USE AND CONSULT A PHYSICIAN. TO AVOID TRAUMA TO THE PERIWOUND SKIN, DO NOT PULL OR STRETCH THE DRAPE OVER THE FOAM DRESSING DURING DRAPE APPLICATION. EXTRA CAUTION SHOULD BE USED FOR PATIENTS WITH NEUROPATHIC ETIOLOGIES OR CIRCULATORY COMPROMISE. ALWAYS ENSURE THAT V.A.C.® FOAM DRESSINGS AND V.A.C. VERAFLO¿ THERAPY 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 FINE MESHED, NON-ADHERENT 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 THAT THEY ARE SECURED IN A MANNER AS TO MAINTAIN THEIR PROTECTIVE POSITION THROUGHOUT THERAPY

Description of Event or Problem · 1

ON 23-JUN-2021, THE FOLLOWING INFORMATION WAS RECEIVED BY KCI AFTER A REVIEW OF JOURNAL ARTICLE, SIM, N., ET AL. 20-APR-2021, DOI: 10.1016/J.FOOT.2021.101803. A REVIEW OF THE TURNED-DOWN ONTO PERICAPSULAR-TISSUE HEMISECTIONED AMPUTATED TOE (TOPHAT) FLAP FOR WOUND COVERAGE DURING RAY AMPUTATIONS OF THE TOES THAT NOTED THE FOLLOWING: PAGE 3 UNDER RESULTS NOTED FIVE PATIENTS UNDERWENT NPWTI-D [NEGATIVE PRESSURE WOUND THERAPY WITH INSTILLATION AND DWELL-TIME] FIRST AND UNDERWENT THE TOPHAT FLAP SUBSEQUENTLY AS THE CAPSULE OF THE ADJACENT METATARSUS BECAME GRADUALLY DESICCATED AND EXPOSED ALLEGEDLY FROM THE NPWTI-D. NO ADDITIONAL INFORMATION IS AVAILABLE. ON 15-JUL-2021, THE SINGAPORE SALES REPRESENTATIVE CONFIRMED THAT THE SERIAL NUMBERS WERE NOT AVAILABLE AS THE SURGEON DOES NOT DOCUMENT THAT INFORMATION. THE V.A.C.ULTA¿ THERAPY SYSTEM PRODUCT IDENTIFIERS WERE NOT PROVIDED, AND THE DEVICES WERE NOT AVAILABLE FOR RETURN; THEREFORE, DEVICE EVALUATIONS COULD NOT BE PERFORMED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1117043	V.A.C.ULTA THERAPY SYSTEM	OMP	OMP	KINETIC CONCEPTS, INC.	WNDULT

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R\| S	CULTURE DIRECTED ANTIBIOTIC THERAPY