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 Stroke/CVA (1770); Numbness (2415)

Event Date 05/25/2017

Event Type  Injury  

Event Description

A venaseal device was used for the vein closure procedure of the right great saphenous vein.It was reported that the procedure was completed normally per ifu.The vein closed.Patient experienced unilateral numbness 24 hours post venaseal closure system treatment.The patient was diagnosed as questionable stroke by neurologists.Symptoms improved quickly, but according to the last report, some unilateral numbness remains.It was reported that the brain mri was normal and the cardiac echogram was normal with no evidence of pfo/septal defect.Physician reported that since there has been significant improvement, the diagnosis could perhaps be prind (prolonged reversible ischemic neurological deficit), rather than cva (cerebrovascular accident).It is reported that the physician is unsure, doubtful if the event is related to the venaseal device or procedure.

Manufacturer Narrative

Additional information: it is reported that the patient developed atypical neurological symptoms starting over 24 hours afterwards with fluctuating numbness and weakness of their right arm despite two normal mris of the brain.The patient had generalised lethargy and possible palpitations which can wake them at night.It is believed an echocardiogram has excluded paradoxical thrombo-embolism.A dvt has been excluded.Patient was not treated with any foam sclerosant.The physician notes it is possible that the patient has intermittent tachyarrythmia as a source of their palpitations and possible tia.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

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: 6665473
• MDR Text Key: 78347463
• Report Number: 3011410703-2017-00267
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: SP-101
• Device Lot Number: 45417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2017
• Date Device Manufactured: 11/09/2016
• 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
• Patient Age: 45 YR