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 Pulmonary Embolism (1498); Anaphylactic Shock (1703); Bruise/Contusion (1754); Stroke/CVA (1770); Cyanosis (1798); Ecchymosis (1818); Granuloma (1876); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Phlebitis (2004); Local Reaction (2035); Ulcer (2274); Unspecified Nervous System Problem (4426); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 10/30/2023

Event Type  Injury  

Event Description

Medtronic received an article titled '899 serious adverse events including 13 deaths, 7 strokes, 211 thromboembolic events, and 482 immune reactions: the untold story of cyanoacrylate adhesive closure'.The aim of the study was to retrieve and analyse the serious adverse events of venous occlusion systems used in cyanoacrylate adhesive closure (cac) submitted to regulatory agencies.Publicly available regulatory databases were reviewed and last updated on 1st june 2023.This included the tplc and maude databases of the fda, the database of adverse event notifications (daen) of the australian therapeutic goods administration (tga),and the yellow card database of the u.K.Medicines and healthcare products regulatory agency (mhra).A total of 940 mdr for venaseal¿ have been submitted to the fda and registered on the tplc database since the registration of the product in 2015 and up to and including 1st june 2023.Fda and registered on the tplc database reports by year were retrieved, exported, and analysed.After the removal of duplicates, there were 899 individual reports.There were 837 reports of injury and 13 deaths.The most reported ¿device problems¿ were ¿adverse events without identified device or use problem¿ (489), ¿biocompatibility¿ (299), and ¿patientdevice incompatibility¿.The most frequent ¿patient problems¿ included ¿hypersensitivity/allergic reaction¿ (204), ¿thrombosis/thrombus¿ (192), and ¿unspecified infection¿ (91).Severe adverse outcomes included ¿death¿ (13), ¿pulmonary embolism¿ (36), ¿stroke/cva¿ (7), ¿sepsis¿ (11), ¿anaphylactic shock¿ (1), and ¿quadriplegia¿ (1).There were a total of 21 neurological adverse events, 211 thromboembolic adverse events, 482 immune reactions, and 129 infections.Daen database (australian therapeutic goods administration (tga) reported events included one incident citing ¿inflammatory changes¿, and one incident citing ¿thrombophlebitis, pulmonary emboli, a major embolic stroke and a painful peripheral inflammatory neurosarcoidosis in the legs approximately 2-months post procedure¿.The yellow card database (uk-mhra) was searched and seven adverse incident reports were identified.The agency would not disclose which device was implicated in the air citing exemptions under sections 41(1) and 43(2) of the foia.Five incidents considered to be serious and a further two considered minor.There were three incidents of infections, one report of granuloma formation, one incident of pe, one incident of hypersensitivity, and one incident of ¿multiple complications¿ that included thrombophlebitis, pulmonary embolism (pe), and leg ulcers requiring a high tie venectomy.A literature search of medline, embase, and cochrane databases was also performed.The comprehensive literature search of the english language medical databases identified 58 relevant records which included systematic reviews, randomised control trials, cohort studies, and case reports.There was one cochrane review on different interventions for great saphenous vein (gsv) incompetence which included cyanoacrylate glue.There was one report of death from turkey with the use of venablock, three reported cases of pe, and ten cases of deep vein thrombosis (dvt).Septicaemia was reported in one patient and temporary blindness in another case.The most common reported adverse events were phlebitis, type iv hypersensitivity allergic reaction, foreignbody granuloma formation, and endovenous glue-induced thrombosis (egit).Other reported complications included pigmentation, paraesthesia, ecchymosis, and glue protrusion from the skin.

Manufacturer Narrative

Literature ref: doi: 10.1177/02683555231211086.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.

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.

Event Description

Medtronic received an article titled '899 serious adverse events including 13 deaths, 7 strokes, 211 thromboembolic events, and 482 immune reactions: the untold story of cyanoacrylate adhesive closure'.The aim of the study was to retrieve and analyse the seriousadverse events of venous occlusion systems used in cyanoacrylate adhesive closure (cac) submitted to regulatory agencies.Publicly available regulatory databases were reviewed and last updated on 1st june 2023.This included the tplc and maude databases of the fda, the database of adverse event notifications (daen) of the australian therapeutic goods administration (tga),and the yellow card database of the u.K.Medicines and healthcare products regulatory agency (mhra).A total of 940 mdr for venaseal¿ have been submitted to the fda and registered on the tplc database since the registration of the product in 2015 and up to and including 1st june 2023.Fda and registered on the tplc database reports by year were retrieved, exported, and analysed.After the removal of duplicates, there were 899 individual reports.There were 837 reports of injury and 13 deaths.The most reported ¿device problems¿ were ¿adverse events without identified device or use problem¿ (489), ¿biocompatibility¿ (299), and ¿patientdevice incompatibility¿.The most frequent ¿patient problems¿ included ¿hypersensitivity/allergic reaction¿ (204), ¿thrombosis/thrombus¿ (192), and ¿unspecified infection¿ (91).Severe adverse outcomes included ¿death¿ (13), ¿pulmonary embolism¿ (36), ¿stroke/cva¿ (7), ¿sepsis¿ (11), ¿anaphylactic shock¿ (1), and ¿quadriplegia¿ (1).There were a total of 21 neurological adverse events, 211 thromboembolic adverse events, 482 immune reactions, and 129 infections.Daen database (australian therapeutic goods administration (tga) reported events included one incident citing ¿inflammatory changes¿, and one incident citing ¿thrombophlebitis, pulmonary emboli, a major embolic stroke and a painful peripheral inflammatory neurosarcoidosis in the legs approximately 2-months post procedure¿.The yellow card database (uk-mhra) was searched and seven adverse incident reports were identified.The agency would not disclose which device was implicated in the air citing exemptions under sections 41(1) and 43(2) of the foia.These included one incident resulting in death, five incidents considered to be serious, and a further two considered minor.There were three incidents of infections with one leading to death, one report of granuloma formation, one incident of pe, one incident of hypersensitivity, and one incident of ¿multiple complications¿ that included thrombophlebitis, pulmonary embolism (pe), and leg ulcers requiring a high tie venectomy.

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: 18244763
• MDR Text Key: 329432805
• Report Number: 9612164-2023-05742
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 01/30/2024

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: 11/03/2023
• Initial Date FDA Received: 12/01/2023
• Supplement Dates Manufacturer Received: 11/03/2023; 01/30/2024
• Supplement Dates FDA Received: 12/01/2023; 01/30/2024
• 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): Other