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

Device Problem Biocompatibility (2886)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Local Reaction (2035); Swelling/ Edema (4577); Peripheral Edema (4578)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Incidence and clinical impacts of cynoacrylate induced soft tissue allergic reaction among patients who underwent venaseal procedure.Annals of vascular diseases 2021:14(89).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

Cyanoacrylate glue adhesion (ca) is the latest endovenous surgery for chronic venous disease.However, published studies on type iv hypersensitivity after ca showed heterogeneous results in incidence, duration, skin manifestation, and risk factors.From mar 2019 to december 2020, 293 patients who underwent ca procedure were evaluated.Type iv hypersensitivity was identified in 101 cases presented with itching, erythma, painful swelling, heating sense, perivascular edema, and pigmentation.Beyond the local response, systemic manifestation was identified in 18 patients of caistar developed within 3 weeks and last up to 2 weeks.Severe caistar, defined as lasting longer than 3 weeks and combined systemic extension, was noted in 40% of total ca procedure.Caistar was not affect to 1 month and 3 months post operative satisfaction score ranges.When it was compensated for sex, age, bmi and procedure lesion, the multi-variated analysis showed male sex and below the knee lesion procedure were major risk factors of caistar development.Peri-operative steroid injection did not reduce the incidence of caistar, but delayed the onset time and also might reduce the duration, itching sense and severity.Caistar is not an uncommon complication, with an incidence of 34% after the ca procedure.Natures are similar with type iv allergic response and generally benign course.

• 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: 14975529
• MDR Text Key: 295602277
• Report Number: 9612164-2022-02587
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• 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?: Yes
• Date Manufacturer Received: 06/27/2022
• 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 Age: 61 YR
• Patient Sex: Male