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

Model Number GELWEAVE VALSALVA

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

Patient Problems Aneurysm (1708); Myocardial Infarction (1969); Sudden Cardiac Death (2510)

Event Date 05/25/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).Process evaluation- review of retained qc and manufacturing records carried out.Result code -failure detected - batch manufactured to design specification conclusion code- conclusion not yet available - evaluation of returned explant in progress.

Event Description

The event was described to vascutek (b)(4); patient died suddenly during the night between 4th and 5th post-operative days after a bental procedure.Gelweave valsalva was used with perimount magna ease edwards lifsciences valve.In medico-legal postmortum found thrombus mass at the ostia of both coronaries and ischemia in myocardial tissue.At the moment it seems that the patient died of acute myocardial ischemia caused by thrombus blocking both coronary ostia.The final medico-legal report is not available yet.Post-operative phase going well.Patient was getting better.3 hours before death patient had reported shoulder and chest pain which probably passed with medication ".

Manufacturer Narrative

Method: section of actual device evaluated.Method: visual inspection of returned sample carried out.Method: scanning electron microscope(sem) examination of returned sample carried out.Result: no failure detected, no flaws or defects found on returned sample.Conclusion: unable to confirm complaint.Returned section free from defects.Conclusion: no failure or insufficiency was found with the sample tested.This issue will be tracked and trended as part of the routine complaints monitoring and reporting process.If an adverse trend develops, action may be taken at that time.Vascutek now considers this complaint as closed.

Event Description

This report is being submitted as a follow up #1 for mfg report no.9612515-2015-00024 to provide new information.

• Brand Name: GELWEAVE
• Type of Device: GELWEAVE VALSALVA
• 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: 5070230
• MDR Text Key: 25533283
• Report Number: 9612515-2015-00024
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K013022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 08/14/2015,09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: GELWEAVE VALSALVA
• Device Catalogue Number: 730028ADP
• Device Lot Number: 345531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/14/2015
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/14/2015
• Date Manufacturer Received: 08/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2014
• 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): Death
• Patient Age: 67 YR
• Patient Weight: 84