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

Device Problem Biocompatibility (2886)

Patient Problems Granuloma (1876); Unspecified Infection (1930); Skin Inflammation (2443)

Event Date 08/15/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used venaseal occluding device to treat the great saphenous vein and short saphenous vein.It was reported that 12 days post procedure, patient suffered redness and itching inside the right leg.Event was treated with antibiotics.14 days post procedure, patient suffered mild phlebitis and was treated with medrol dose pack.21 days post procedure, follow up, cyst was removed from the right thigh unrelated to venaseal procedure.Four weeks post procedure, patient suffered redness irritation at the access site mid and proximal calf.Approximately 6 weeks post procedure, patient was seen due to wound developing on mid medial leg at the site of venous access.Also, redness in the proximal calf.Wound was scanned and proximal calf redness and glue was visualised under ultrasound.Physician removed glue out of subcutaneous tissue and performed wound care.Patient was given doxyclycline.Proximal redness was not treated.It was reported patient developed granuloma over treatment access site.

Manufacturer Narrative

Additional information: the catheter was 5cm caudal to the saphenous femoral junction (sfj) prior to initial delivery of adhesive.Compression of gsv was performed.Patient is doing well; proximal calf redness irritation has resolved and the access site at the medial calf looks fine.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: eight photographic images were received in which four were of sonographic images.The first image is of the patient¿s right medial m id-calf access site.The access site appears to be eschar and is surround with redness.It is not known which post-procedure office visit the image is from.The second image is a close-up of the first image.The third image is of a sonographic image and shows a sonographic reflective mass within the vessel.The fourth image is a close-up of the third image.The fifth image is of the patient¿s right medial mid-calf access site.The access site appears to be eschar and is surround with redness.The amount of eschar and redness surrounding the access site is less than the first set of photographs.It is not known which post-procedure office visit the image is from.The sixth image is a close-up of the fifth image.The sixth image is of a sonographic image and shows a sonographic reflective mass within the vessel.The date on the image indicates it was from (b)(6) 2019.The fourth image is a close-up of the sixth image.The seventh image is of excised adhesive from the wound from the office visit on (b)(6) 2019.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: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9145483
• MDR Text Key: 162085084
• Report Number: 9612164-2019-04196
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2019

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?: Yes
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: 11/12/2019; 12/09/2019
• Supplement Dates FDA Received: 11/13/2019; 12/10/2019
• 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: 67 YR
• Patient Weight: 104