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

Catalog Number SP-101

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

Patient Problems Pulmonary Embolism (1498); Unspecified Infection (1930); Pneumonia (2011); Sepsis (2067); Thrombosis/Thrombus (4440); Unspecified Respiratory Problem (4464)

Event Date 08/17/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

Physician used venaseal during procedure to treat the small saphenous vein (ssv).General anesthesia was used.The vein closed effectively.The lumen was flushed prior to use.Ifu was followed.A guidewire was used for the insertion and placing of the catheter.The catheter tip was 5 cm caudal to the sfj.Compression of the gsv was applied.The event was not caused by the product.The procedure was completed without any problems.The was no ehit findings.One day post procedure, no ehit or symptoms.Eight days post procedure, no ehit findings.Eleven days post procedure, patient visited hospital complaining of difficulty in breathing.Saturation was 88 to 90.However, when it was measured again, it recovered to 94 and then decided to "wait and see." thirteen days post procedure, patient complained of difficulty in breathing again and referred to a hospital, but was postponed because it was a sunday.Fifteen days post procedure, patient complained of breathing and returned to the hospital again and was referred to another hospital, and patient was examined.Severe pulmonary embolism was noted and the patient was hospitalized.Deep vein thrombosis (dvt) were noted in both legs.Sixteen days post procedure, patient received treatment with ecmo.No further patient injury reported.

Manufacturer Narrative

Additional information: currently the patient is being transferred to another hospital.Patient's condition details are unknown.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

Additional information: both small saphenous veins were treated during the initial venaseal procedure.No thrombus was found near junction after venasseal p rocedure.The soleus muscle vein, which was a dvt-prone site, was not examined.The physician suspect there may have been a thrombus in the peripheral part, soleus muscle vein, from the junction, but it could not have been found.Only the right side had varicectomy performed.Elastic bandage for 1 week was done for only the right and eight days later, the elastic bandage was taken off.The patient received consultation as the patient would "like to walk for about 30 minutes and go shopping".The patient had almost no activity for about seven days until the last visit.The physician allowed the patient to leave almost as usual, but the dvt may have developed by resting.One month post elastic bandage was taken off and 6 weeks post index procedure, the physician in charge in the other hospital was informed that "blood pressure is falling and it is severe" in the morning.The patient expired later the same day and the cause of death was reported to be complications such as infection, sepsis, and pneumonia.Approximately 2 months post index procedure, the physician in charge in the other hospital was notified of the patient's death and did not perform pathological autopsy.The physician could not contact the bereaved family anymore due to timing.There is no contact or post-confirmation from the patient's bereaved family to the clinic.There was no report of thrombophilia from the physician in charge of the other hospital.Dvt was not confirmed in the patient's medical history.Final causal relationship between patient death and use of the device is unknown as no pathological dissection was conducted.Determining causal relationship with the device is unknown as well.Causal relationship with the procedure is unknown as well.Generally e-hit or e-git is not conducted at closely monitoring the patient after the procedure.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
• MDR Report Key: 12370049
• MDR Text Key: 268220341
• Report Number: 9612164-2021-03309
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2021

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 Catalogue Number: SP-101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 09/14/2021; 10/01/2021
• Supplement Dates FDA Received: 09/15/2021; 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 49