MAUDE Adverse Event Report: VASCUTEK LTD. AX-BIFEM EQUI-FLO ERS REINFORCED

Model Number 691008B

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

Patient Problem Infarction, Cerebral (1771)

Event Date 08/18/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Vascutek have carried out a review of similar events and the occurrence rate for this type of defect is found to be 0.004% and therefore is very low.Vascutek now consider this case closed however the event type will be tracked and trended through the complaints monitoring program and if an adverse trend is identified corrective action may be considered at that time.Device not returned to manufacturer.

Event Description

The event was reported to vasctuek as follows; the graft was implanted via debranch tevar technique.Subsequent echographic investigation (date unknown) found a clot formation at approximately 4cm proximal to the bifurcation of the graft.The clot was removed by implementation of pta and drug administration.Some days later (exact time unknown) the patient developed a cerebral infarction.The cause of the cerebral infarction is unknown.

• Brand Name: AX-BIFEM EQUI-FLO ERS REINFORCED
• Type of Device: AX-BIFEM EQUI-FLO ERS REINFORCED
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, scotland PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, scotland PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: carolyn forrest ; newmains avenue; inchinnan business park; renfrewshire, scotland PA4 9-RR ; UK PA4 9RR ; 1418125555
• MDR Report Key: 5969476
• MDR Text Key: 55322582
• Report Number: 9612515-2016-00024
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K002007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/24/2016,09/23/2016

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 Expiration Date: 11/30/2019
• Device Model Number: 691008B
• Device Catalogue Number: 691008B
• Device Lot Number: 348808/01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 21 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2016
• Initial Date Manufacturer Received: 08/24/2016
• Initial Date FDA Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2014
• 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): Life Threatening