MAUDE Adverse Event Report: MEDTRONIC IRELAND VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT

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

Patient Problems Fever (1858); Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)

Event Date 09/20/2022

Event Type  Injury  

Manufacturer Narrative

Title: septicemia after cyanoacrylate glue closure of varicose veins journal: journal of vascular surgery cases, innovations and technique issue: 2022, vol 8, issue 4 authors: masato nishizawa, md, phd toshifumi kudo, md, phd reference: doi.Org/10.1016/j.Jvscit.2022.09.008 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic was notified of a journal article case report 'septicemia after cyanoacrylate glue closure of varicose veins' an 82-year-old woman had presented to another clinic with a 6-month history of dermatitis of the lower legs and had been treated by another vascular surgeon before referral to our hospital.She had a medical history of hypertension and dyslipidemia but no allergies or hypersensitivity reactions.She was diagnosed with ceap (clinical, etiologic, anatomic, pathophysiologic) clinical class 4a stasis dermatitis on the distal dorsal side of the lower legs.No cellulitis was present on either leg.Duplex ultrasound revealed bilateral incompetent small saphenous veins (ssvs).Given her symptoms and ssv incompetence, the surgeon at the previous clinic had decided to perform endovenous cac (venaseal closure system; medtronic, minneapolis, mn).On the day of the procedure, the patient was afebrile.The skin was prepared using 0.05% chlorhexidine before sterile draping.A sterile cac device package within the sterilization date was opened and used.With the patient under local anesthesia, the ssvs were cannulated at the dorsal distal part of the lower legs.A standard 7f sheath and a sapheon outer catheter (medtronic) were fed into the vein and placed distal to the saphenopopliteal junction.Glue injection was repeated nine times (21 cm; total of 0.9 ml) on the right side and eight times (19 cm; total of 0.8 ml) on the left side.After the procedure, the puncture sites were closed with steri-strips (3m, st paul, mn) and covered with an a dhesive waterproof dressing.The total operative time was 28 minutes.No anatomic abnormalities were observed, and no postoperative hematoma developed.Duplex ultrasound after the procedure confirmed successful occlusion of the ssvs and a patent deep venous system.No prophylactic antibiotics were administered during or after the operation.The patient did not receive postoperative compression therapy.On the night of postoperative day (pod) 2, the patient reported pain and heat in her left calf.She subsequently developed a low-grade fever of 37c.On pod 4, redness and swelling were observed in her left lower limb.The glue plug did not extrude.Ultrasound examination revealed no exudate.The patient was diagnosed with a foreign body reaction and treated with oral steroids (10 mg/d).On pod 7, her fever had increased to 38c.An infection caused by the cac was suspected.On referral to our department from the previous clinic, the patient was immediately hospitalized.Computed tomography (ct) of both calves revealed no abscesses.Two bacterial cultures of blood samples confirmed the presence of methicillinsensitive staphylococcus aureus (mssa).Antibiotics (cefazolin 3 g/d) were administered.Two days after admission, the patient underwent surgery under tumescent anesthesia to excise the bilateral ssvs.Pus was found in the lumen of the left ssv, and the corresponding bacterial culture was positive for mssa histologic examination of the excised ssv specimens was subsequently performed.Inflammatory cell infiltration was observed from the intima to the adventitia of the vein wall.This mainly comprised mononuclear cells containing neutrophils.Inflammatory cell infiltration was also observed in the adipose tissue around the excised blood vessels.The intima was thickened, and necrotic exudate was present.However, gram staining revealed no bacteria cellsz postoperatively, the patient had a persistently high fever of 39c to 40c, and her inflammatory marker levels remained elevated (white blood cell count, 12,900/ml; c-reactive protein, 21.45 mg/dl).She also reported lower back pain.On pod 6 after the second surgery, contrast-enhanced ct revealed abscess formation in the right greater psoas and erector spinae muscles and bilateral patent deep venous systems with no thrombi.Contrast-enhanced ct on pods 20, 34, and 50 also revealed no thrombi in the bilateral deep venous system.Antibiotic therapy was continued, and the patient fully recovered.Her surgical wound healed well.She was discharged on pod 42.At 21 months of follow-up, the patient had not experienced any recurrence of an allergic reaction or infection.The article hypothesized that, in this case, the source of the infection was the catheter insertion site.They excised the bilateral ssvs to prevent bacteremia in the right leg due to glue infection.Although no significant symptoms were observed in the right leg at surgery, it could not be confirmed whether the right leg glue had already become infected.The patient could also have had an allergic reaction to the glue.Our patient developed abscesses in the right greater psoas muscle and erector spinae muscles.Although the precise mechanism was unclear, it was presumed that the bacteria had been hematogenously implanted in the muscles owing to the bacteremia.It could not be determined whether the patient¿s fever and inflammatory response were caused by the muscle abscesses or the cac itself.In either case, it appeared to be an iatrogenic event caused by the cac procedure, followed by puncture site infection.However, the rapid onset of the septicemic manifestations suggested that the infection might have begun preoperatively, despite the absence of overt manifestations or cellulitis on the day of surgery.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15798024
• MDR Text Key: 303648266
• Report Number: 9612164-2022-04248
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/16/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 11/27/2022
• Supplement Dates FDA Received: 12/04/2022
• 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
• Patient Age: 82 YR
• Patient Sex: Female