MAUDE Adverse Event Report: SAPHEON / MEDTRONIC VENASEAL CLOSURE SYSTEM-CE MARK; AGENT, OCCLUDING, VASCULAR, PERMANENT,

Model Number SP-101

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

Patient Problem Reaction (2414)

Event Date 07/04/2014

Event Type  Injury  

Event Description

Patient presented with an insufficient great saphenous vein (gsv).The physician treated the vein with the venaseal closure system from the sapheno-femoral junction (sfj) using 1.7 ml venaseal cyanoacrylate adhesive.The intervention was uneventful.No additional compression therapy was administered.Examination on first post-operative day and at the two week follow-up period showed a fully closed gsv, however the patient reported some itching on the inner surface of his lower extremities.The ultrasound examination revealed a diffuse liquid-orbit around the gsv.The patient consulted with a dermatologist after reoccurring itching on both legs and arm surfaces.Nine months a full allergy diagnostic was performed using a prick test with exposition of cyanoacrylate to one arm of the patient.After two days no explicit reaction could be detected, but after two weeks they achieved a positive result of an allergic reaction type 1, that was successfully treated with xusal.Re-examination a number of weeks later showed a good response to the treatment, with no liquid assembly around the gsm, no bruising or itching.

Manufacturer Narrative

(b)(4).A capa has been opened to manage the actions related to remediation of complaint files and any required mdr reporting.

Manufacturer Narrative

After review of the manufacturing report number, it was determined that the mdr was submitted under the incorrect number.The original manufacturing report number that was generated was 1282497-2015-00002, which should have been 3011410703-2015-0002.The original mdr number 1282497-2015-00002 was submitted by the correct due date of june 6, 2015, with a receipt message id: (b)(4).

Event Description

This procedure was performed in (b)(6).Customer states that the patient was treated with the venaseal closure system six months ago (somewhere in (b)(6) 2014).He has shown an allergically reaction type 1 with hives.Now he is treated with histamine antagonist.Procedure: cvi treatment.With non-thermal, non-tumescence, endoluminal technique.No further intervention required.Device destroyed by user.

Manufacturer Narrative

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

• Brand Name: VENASEAL CLOSURE SYSTEM-CE MARK
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT,
• Manufacturer (Section D): SAPHEON / MEDTRONIC; 951 aviation parkway; morrisville NC 27560
• Manufacturer (Section G): SAPHEON/MEDTRONIC; 951 aviation parkway; morrisville NC 27560
• Manufacturer Contact: mary haufek ; 951 aviation pkwy; suite 900; morrisville, NC 27560 ; 7633987000
• MDR Report Key: 4838740
• MDR Text Key: 43847067
• Report Number: 3011410703-2015-00002
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SP-101
• Device Catalogue Number: SP-101
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention
• Patient Age: 41 YR