MAUDE Adverse Event Report: SAPHEON INC 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 Foreign Body Reaction (1868); Pain (1994); Reaction (2414)

Event Date 06/01/2017

Event Type  Injury  

Event Description

Physician employed the use of a venaseal closure system for treatment of bilateral greater saphenous veins (gsv) on (b)(6) 2017.Ifu was followed and the procedure was performed as per normal without issue.It was reported that 2.5 ml of the glue was reportedly used to treat 45 cm length of the right gsv; and 2.0 ml glue was used to treat 40 com gsv on the left leg.Patient was given post procedure follow-up instructions.During the follow-up visit on (b)(6) 2017, redness was noted on bilateral legs.Patient was prescribed a topical anti-coagulant gel (lioton)and a topical nsaid gel (fastum).During the follow-up patient visit on (b)(6) 2017, patient complained of pain and redness of both thighs.A hematoma/granuloma/thrombotic extension (diameter 22mm) was found on the right leg under ultrasound guidance.This was punctured and drained.Patient was prescribed an antibiotic therapy (ciprinol), a top ical anti-coagulant gel (lioton)and a topical nsaid gel (fastum).During the third follow-up visit on (b)(6) 2017, there was reportedly less pain in both the legs.The redness had reduced.The hematoma/granuloma on the left leg was less aggravated.During the visit on (b)(6) 2017, there was no longer complaint of pain and feeling of heavy legs.The diameter of extension/hematoma/granuloma was reduced to 15 mm.Patient was prescribed a venotonic medicine (detralex), topical lithium gel and aspirin.

Manufacturer Narrative

Additional information: a single sonographic image from the follow-up on (b)(6) 2017 was received for evaluation.Due to the quality of sonographic image it was not possible to determine if the image is of a round mass, or a transverse view through a vein.There were no histological/pathological tests performed to confirm the inflammation to be as granuloma.Granuloma has now been resolved.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): SAPHEON INC; 951 aviation pkwy ste 900; morrisville NC 27560
• Manufacturer (Section G): SAPHEON INC; 951 aviation pkwy ste 900; morrisville NC 27560
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6819656
• MDR Text Key: 83606859
• Report Number: 3011410703-2017-00337
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: LO
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/11/2017

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2017
• Initial Date FDA Received: 08/25/2017
• Supplement Dates Manufacturer Received: 09/11/2017
• Supplement Dates FDA Received: 10/10/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 44 YR