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

Model Number SP-101

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

Patient Problem Pulmonary Embolism (1498)

Event Date 04/01/2015

Event Type  Injury  

Manufacturer Narrative

Event date and implant date are an approximate.

Event Description

Physician performed a venous intervention using the venaseal closure system.The procedure was uneventful, with no complications.Post-operative ultrasound 1 day after the surgery showed closure of the gsm as desired.Two days after the intervention, the patient was driving in his motor vehicle for a considerable length of time, approximately 5 hours.A few days after, the patient experienced breathing problems and was hospitalized.The diagnosis was a bilateral pulmonary embolism.The treatment was conducted by administering xarelto for anticoagulation.During the examination the deep vein system was completely free of any thrombus formation, while the gsv was occluded as intended.The hospital physician also excluded a thrombus extension onto the deep system and any intrusion of glue outside the gsv.The physician felt that under the circumstances the pulmonary embolism would have also occurred if the patient was treated with any thermal ablation or stripping method.

Manufacturer Narrative

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

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 1282497-2015-00003, which should have been 3011410703-2015-0003.The original mdr number 1282497-2015-00003 was submitted by the correct due date of (b)(6) 2015, with a receipt message id: (b)(4), and a common device name of (b)(4).(b)(4).

Event Description

This procedure was performed in (b)(6).Customer stated that the patient was treated with the venaseal closure system - somewhere in (b)(6) 2015.Two days after this treatment he has had pulmonary embolism.He got an anticoagulant therapy with marcumar.Procedure: cvi treatment with nonthermal, non-tumescence, endoluminal technique.No further intervention required.Device destroyed.

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, PRODUCT CODE:
• Manufacturer (Section D): SAPHEON / MEDTRONIC; 951 aviation parkway; morrisville NC 27560
• Manufacturer (Section G): SAPHEON/MEDTRONIC; 951 aviation parkway; morrisville NC 27560
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 33987000
• MDR Report Key: 4838817
• MDR Text Key: 43848633
• Report Number: 3011410703-2015-00003
• 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

• 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
• Initial Date Manufacturer Received: 05/07/2015
• Initial Date FDA Received: 06/11/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 05/07/2015
• Supplement Dates FDA Received: 06/11/2015; 03/31/2016; 10/05/2017
• 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