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 Problem Hematoma (1884)

Event Date 05/14/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During initial procedure, venaseal occluding device was used to treat 16.0cm of the small saphenous vein (ssv).Puncturing was performed from below the knee, and the target treatment was completed without problems.Postoperative dus was noted as no patency.Physician prescribed loxoprofen for 7 days.Patient had never been treated for lower limb varicose vein in both legs.There was no blood clot before the first procedure.At 7-10 days ((b)(6) 2020) follow-up, there was no adverse event, device malfunction, or patency of the treatment vein.At one month follow-up, there was no adverse event, device malfunction, or patency of the treatment vein.At the 49th day post procedure, the patient visited the hospital with bleeding from the posterior surface of the right lower leg.Although there was no pain, hematoma appeared from the puncture site on the appearance, so physician performed compression and discharged.The treated blood vessel was blocked by echo.Physician commented that the hematoma had a causal relationship with the product because it coincided with the treatment site, the causal relationship with the procedure was unknown, and the severity was non-serious.The patient recovered on the same day.There were no issues or deviations related to the position of the catheter tip prior to the initial delivery of the adhesive.The tip of the catheter was 16.0cm from the caudal side of the sfj.The were 7 pushing of the adhesive dose to the treated vein.No further patient injury reported.

Manufacturer Narrative

Additional information: physician prescribed loxoprofen as part of post-operative care.No other treatment was given to the patient for the hematoma.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: a single photographic image of the patient¿s lower right leg just below the knee was returned for evaluation.A hematoma is visible and dark blood is being expressed from the wound.Per the reported event description this happened on the 49th day post-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.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
• MDR Report Key: 10179997
• MDR Text Key: 195963695
• Report Number: 9612164-2020-02284
• 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: 07/17/2020

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: 06/30/2021
• Device Catalogue Number: SP-101
• Device Lot Number: 55952
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 06/24/2020; 07/15/2020
• Supplement Dates FDA Received: 06/29/2020; 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 65