MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE VALSALVA

Catalog Number 730032ADP

Device Problem Obstruction of Flow (2423)

Patient Problems Cardiac Arrest (1762); Infarction, Cerebral (1771); Thrombus (2101); Sudden Cardiac Death (2510)

Event Date 07/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).On (b)(6) postoperatively, 6 hours after the scheduled surgery, the patient had a massive infarction complicated by cardiac arrest that required a coronography showing left coronary artery occlusion warranting emergency resurgence for bypass surgery.Just before re-intervention, the patient had a cardiac arrest requiring ecls.During reintervention, thrombus of the aortic pellet was found to mold the valve and aortic prosthesis and to obstruct the common trunk.Thrombus extraction and double bypass were performed.During follow-up, the patient presented a multi-organ failure leading to his death on (b)(6) 2018 in intensive care at day 1.(b)(4).The manufacturing and qc records for this batch were retrieved and reviewed.Batch was manufactured to design specification.No further complaints have been received from this batch to date.Similar events review that was carried out for gelweave valsalva grafts with occlusion/thrombosis events gave a low occurrence rate of (b)(4).Vascutek are awaiting further information from site.

Event Description

Event was reported to vascutek as follows: gelweave valsalva graft was used for bentall procedure.Extensive thrombosis of the vascular graft occurred few hours after surgery, requiring surgical revascularization.Patient died of massive infarction.

Event Description

This report is being submitted as follow up # 1 for mfr.Report to provide additional information that was received from the customer.More detailed event description was received on 19 jul 18: the patient was hospitalised for bentall elective surgery for annulo-ectasia disease with severe aortic leakage.Valved tube made of valsalva 32 tube and edwards carpenter perimount bio prosthesis of 27 gauge.Simple intervention clamping 74 min, cec 85 min, total duration 190 min.The immediate follow-up was simple correct hemodynamics, (no transfusion, no haemostatic products).On 6 july postoperatively, 6 hours after the scheduled surgery, the patient had a massive infarction complicated by cardiac arrest that required a coronography showing left coronary artery occlusion that lead to the emergency bypass surgery.Just before re-intervention, the patient had a cardiac arrest requiring ecls.During reintervention, thrombus of the aortic pellet was found to mold the valve and aortic prosthesis and to obstruct the common trunk.Thrombus extraction and double bypass were performed.During follow-up, the patient presented a multi-organ failure leading to his death on (b)(6) 2018 in intensive care at day 1.

Manufacturer Narrative

Conclusion: 4315 cause not established.Manufacturer could not carry out further device analysis as it remains in situ.However, in the event intake form provided by the customer it was noted that the event was not caused by thrombopenia induced by heparin.Anapath evaluation report of thrombus showed following results: a circular thrombus 3.5 cm in diameter and 1.5 to 2 cm in height with a small "outgrowth" perpendicular to the center of 1.5 cm in height.A detached fragment of 1 x 0.2 cm.Cut transversally and included in total in 5 blocks (blocks 1 to 5).On the different plans examined, a fibrino-hemorrhagic material containing blood figured elements was observed, with quite a few polynuclear.A beginning of organization in streaks was observed.Focally, on two blocks (2 and 4) the presence of exogenous material, bluish, thrombus molded were observed, the nature of which cannot be specified.Vascutek ltd now considers this complaint closed.Further action is not planned; however, the issue will be tracked and trended as part of the on-going complaints trending and reporting process and if an adverse trend develops action may be taken at that time.

• Brand Name: GELWEAVE
• Type of Device: GELWEAVE VALSALVA
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 7768055
• MDR Text Key: 116595904
• Report Number: 9612515-2018-00010
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881120140
• UDI-Public: 05037881120140
• Combination Product (y/n): N
• PMA/PMN Number: K013022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 07/12/2018,09/07/2018

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: 01/31/2021
• Device Catalogue Number: 730032ADP
• Device Lot Number: 17128740-0857
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/11/2018
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2018
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: 07/12/2018
• Supplement Dates FDA Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 87