MAUDE Adverse Event Report: VASCUTEK LTD. GELWEAVE; GELWEAVE STRAIGHT

Model Number GELWEAVE

Device Problems Fungus in Device Environment (2316); Device Contamination With Biological Material (2908)

Patient Problems Death (1802); Hemorrhage, Subarachnoid (1893); Fungal Infection (2419)

Event Date 07/30/2014

Event Type  Death  

Event Description

The event was reported to vascutek as follows: on (b)(6) 2014, an elective aortic procedure (avr/tube graft replacement) of the aorta was completed at (b)(6), a vascutek manufactured gelweave straight graft was implanted; however, during the procedure, it became apparent that the native heart valve could not be salvaged; thus a medtronic valve was implanted in combination.Pt was released from hosp.On (b)(6) 2014, the pt was in (b)(6), the pt developed a fever and word finding difficulties, and was admitted to the emergency room at (b)(6).A head ct scan revealed an acute subarachnoid haemorrhage and a cta of thorax showed a mass in the area of the replaced valve.On (b)(6) 2014, the pt underwent surgery at the (b)(6) to remove and replace the ascending aortic graft and valve.It appeared during surgery that the graft had a fungal infection present, which was later identified as rhizopus.The (b)(4) manufactured graft and valve were explanted and replaced with devices from unconfirmed manufacturers (graft and valve).Post operatively ((b)(6) 2014), the pt had some remaining infection but was recovering well.On (b)(6) 2014, the pt died.(b)(4) are currently attempting to obtain redacted pt medical records, post-mortem report and ct scans from (b)(6), to aid our investigations to determine root cause.

Manufacturer Narrative

Method: the graft has not been returned to vascutek ltd., for analysis.It is not known if the device will be returned.A review of the retained manufacturing records and the associated processes has been completed.A review of the sterilisation process and results has been completed.Results: no results are available as no device has been returned to vascutek for analysis.Review of the retained manufacturing and sterilisation records has identified no abnormalities.Conclusions: vascutek are unable to confirm the complaint as no device has been returned to vascutek for analysis.No definitive conclusion is available.Rhizopus is an environmental fungus which thrives in rotting vegetation.Vascutek has no historical evidence of this fungus recorded through our environmental monitoring programme.This incident report has been submitted within 30 days, as initial investigations indicated that the event was not reportable.However, subsequent investigations have found that this was a reportable event and that the reporting site had also reported this event to the fda.Vascutek has raised an ncr for failing to report this incident in a timely manner.

• Brand Name: GELWEAVE
• Type of Device: GELWEAVE STRAIGHT
• Manufacturer (Section D): VASCUTEK LTD.; newmains ave.; inchinnan business park; renfrewshire, scotland PA4 9RR; UK PA4 9RR
• Manufacturer Contact: steven arik ; 6200 jackson rd; ann arbour, MI 48103-9300 ; 7346634145
• MDR Report Key: 4336728
• MDR Text Key: 5221165
• Report Number: 9612515-2014-00017
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/14/2014,12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: GELWEAVE
• Device Catalogue Number: 736012
• Device Lot Number: 310719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 22 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2014
• Date Manufacturer Received: 10/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• 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): Death; Life Threatening; Required Intervention