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

Model Number SP-101

Device Problem Biocompatibility (2886)

Patient Problems Abscess (1690); Cellulitis (1768); Embolism (1829); Granuloma (1876); Unspecified Infection (1930); Phlebitis (2004); Thrombus (2101); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 05/15/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Patient had left great saphenous vein (gsv) treated with venaseal.Ifu was followed.1-year post-procedure, the patient presented with localized tenderness and infection.The patient¿s left gsv was ligated and removed under general anesthesia.The gsv has been sent for cultures and histology post procedure.No further injury reported.

Manufacturer Narrative

Additional information: lot number provided.The bacterial culture results showed light growth of coliforms.Administration of medicines is not reported.Patient is progressing satisfactorily post removal of the gsv.If information is provided in the future, a supplemental report will be issued.

Event Description

Patient had left great saphenous vein (gsv) treated with venaseal.Ifu was followed.One year post-procedure, the patient presented with localized tenderness and infection.The patient¿s left gsv was ligated and removed under general anesthesia.The gsv has been sent for cultures and histology post procedure.No further injury reported.Update 27-may-2020: the bacterial culture results showed light growth of coliforms.Administration of medicines is not reported.Patient is progressing satisfactorily post removal of the gsv.

Manufacturer Narrative

Additional information: flowsheet print request, operation record - physician notes, and final report were returned to medtronic investigation lab for evaluation.The flowsheet print request includes various lab results which include and compare blood chemistries, haematology, immunology, and micro reports.The document included hand-written notes regarding surgical procedures, discharge notes, follow up appointment, and dressings.No complication was noted in the document.The final report was reviewed and ligation and excision of left saphenous vein, and incision and drainage of left calf abscess.Recent history of venaseal procedure with secondary infection.First specimen labelled "gsv proximal thigh histo", consists of a 120mm vessel segment with a diameter of between 3mm and 7mm.On sectioning the lumen show is partially occluded by gritty cream material.Blocks: 1 -ts ends; 2 to 4 - rs of each third.Second specimen labelled "gsv distal thigh histo", consists of a 110mm full segment with a diameter of between 3mm and 6mm.On sectioning the lumen show is par tially occluded by gritty cream material.Blocks: 1 - ts ends; 2 to 4 - rs of each third.Third specimen labelled "gsv proximal calf histo", consists of a 75mm segment of vessel with a diameter of between 4mm and 7mm.On sectioning the lumen show is partially occluded by gritty cream material.Blocks: 1 -ts ends: 2 to 4 - rs of each third.The three specimens all show similar morphologic features and are described together.Sections of the greater saphenous vein show wi despread thrombophlebitis.The vascular lumen is segmentally occluded by foreign embolic material associated with associated organising thrombus and a foreign-body type granulomatous reaction.The vessel wall shows intimal and medial fibroplasia, with areas of luminal obliteration, as well as, a superimposed florid lymphocytic infiltrate which extends into the adventitial fibroadipose tissue.Occasional giant cells are identified.No significant acute inflammatory infiltrate is seen, and no pathogenic organisms are identified on special stains.There is no evidence of malignancy.The greater saphenous vein shows widespread (granulomatous) thrombophlebitis with luminal embolic material.Whilst these marked fibroinflammatory changes may be secondary to known embolisation, the possibility of a primary inflammatory process, cannot be entirely excluded.Such a primary process may include lymphohistiocytic thrombophlebitis, an underlying primary vasculitis (venulitis) or an infective etiology (although no pathogenic organisms are seen on staining).Correlation with clinical findings is essential.The greater saphenous vein (proximal thigh, distal thigh and proximal calf).Lymphohistiocytic (granulomatous) thrombophlebitis with marked luminal embolic material and segmental fibrointimal.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

Case reported in literature article.Literature reference: infective thrombophlebitis after great saphenous vein cyanoacrylate embolization journal of vascular surgery cases and innovative techniques (2021) 7(3);p577-580 10.1016/j.Jvscit.2021.05.011 additional information from literature article: pre venaseal treatment, the left lower limb duplex ultrasound demonstrated gsv incompetence in the upper thigh and small saphenous v ein incompetence in the lower calf.Examination of the deep system revealed femoral and popliteal vein incompetence and a partially occlusive thrombus extending from the profunda femoris vein to the common femoral vein that proximally involved the stent ostium.The stent was patent.Subsequent computed tomography angiography revealed that the thrombus had completely resolved, although its etiology remained unclear after hematology review and screening for thrombophilia.The entire gsv was treated in accordance with the manufacturer¿s instructions for use.Dabigatran was continued, and no postprocedural hematoma or other complications developed.Postprocedural duplex ultrasound confirmed successful ablation of the gsv and anterior accessory saphenous vein.At 13 months after venaseal treatment, the patient developed a localized infection and abscess over the left calf at the puncture site.The infection was managed with intravenous flucloxacillin, surgical incision, and drainage.An indurated sinus at the puncture site was excised and sent for microbial culture, which yielded no growth.The patient recovered well and was discharged with oral flucloxacillin.The patient presented again 1 month later with a recurrent abscess proximal to the puncture site with associated cellulitis and phlebitis.On examination, tenderness was elicited along the palpable gsv cord from the calf to mid-thigh.No signs of systemic compromise were present.Intravenous flucloxacillin was recommended.Duplex ultrasound demonstrated a compressible gsv in the proximal thigh, which was noncompressible from the mid-thigh to the knee.In the calf, the abscess and surrounding gsv could not be imaged owing to the patient¿s discomfort.During ligation and excision of the gsv, intraoperative examination of the abscess demonstrated fibrosed subcutaneous tissue that was adherent and a firm, enlarged segment of the gsv with purulent exudate.The cyanoacrylate embolization (cae) access site of the previous surgical incision demonstrated fibrotic inflammatory changes and was excised and left open to drain and heal via secondary intention.Following histopathologic examination and bacterial, fungal, and mycobacterial culture of the gsv, bacterial culture yielded growth of citrobacter koseri in the samples from the calf and proximal thigh.The infectious diseases team was consulted, and the patient was transitioned to oral cephalexin for a total of 2 weeks.No mycobacterial or fungal growth resulted from culture of the intraoperative specimen.Histop athologic examination of all segments of the excised vein demonstrated similar morphologic features, including widespread thrombophlebitis, segmental occlusion by foreign body embolic material with associated organizing thrombus, and a foreign body-type granulomat ous reaction.The blood vessel wall demonstrated intimal and medial fibroplasia with a superimposed florid lymphocytic infiltrate, which extended into the adventitial fibroadipose tissue.The postoperative recovery was uncomplicated, and the surgical wound was wel l healed at the outpatient follow-up examination.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

Image review: two images were returned in the literature for evaluation.Image one is photograph showing left calf recurrent abscess proximal to the puncture site with associated cellulitis and phlebitis.Image two is of the great saphenous venectomy.The patient subsequently underwent ligation and excision of the gsv.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
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 10069386
• MDR Text Key: 191536382
• Report Number: 9612164-2020-01906
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/31/2022

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
• Device Expiration Date: 07/31/2020
• Device Model Number: SP-101
• Device Catalogue Number: SP-101
• Device Lot Number: 52058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 05/19/2020
• Supplement Dates Manufacturer Received: 05/27/2020; 06/18/2020; 02/02/2022; 05/26/2022
• Supplement Dates FDA Received: 05/29/2020; 06/19/2020; 02/10/2022; 05/31/2022
• Date Device Manufactured: 07/10/2018
• 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: 45 YR
• Patient Sex: Male