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U.S. Department of Health and Human Services

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

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VASCUTEK LTD. GELWEAVE; GELWEAVE BIFURCATE Back to Search Results
Model Number 732010XL55
Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 07/07/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
This event was reported to vascutek ltd via the panther study programme as follows: on (b)(6) 22 a gelweave bifurcate extra long graft was implanted to treat aorto-iliac stenosis.After procedure an occlusion of the right leg was detected.The patient underwent a thrombectomy of the right leg and femoro-popliteo-jambiere.The issue was considered resolved without sequalae.Patient recovered.The site has indicated that this event is possibly related to the procedure, device and patient pre-existing conditions.
 
Manufacturer Narrative
Section h6 investigation findings: 3221 - no findings available - additional information about the event was requested from the study site on (b)(6) 2022.(b)(6) 2022-09-30, 2022-10-17; however no further information was provided investigation conclusions: 67 - no problem detected - review of the manufacturing records did not identify any problems with the device.4315 - cause not established - the root cause of the event could not be determined, due to lack of information provided.Patient recovered.Adverse event resolved without sequelae.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.
 
Event Description
This report is being submitted as follow up #1 for mfg.Report # 9612515-2022-00013 to provide event closure information.
 
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Brand Name
GELWEAVE
Type of Device
GELWEAVE BIFURCATE
Manufacturer (Section D)
VASCUTEK LTD.
newmains avenue
inchinnan business park
renfrewshire PA4 9 RR
UK  PA4 9RR
Manufacturer (Section G)
VASCUTEK LTD.
newmains avenue
inchinnan business park
renfrewshire PA4 9 RR
UK   PA4 9RR
Manufacturer Contact
jason whittle
newmains avenue
inchinnan business park
renfrewshire PA4 9-RR
UK   PA4 9RR
MDR Report Key15435951
MDR Text Key300036385
Report Number9612515-2022-00013
Device Sequence Number1
Product Code DSY
UDI-Device Identifier05037881107653
UDI-Public05037881107653
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K955230
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/11/2022
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 Expiration Date01/31/2024
Device Model Number732010XL55
Device Catalogue Number732010XL55-G
Device Lot Number21658483
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/23/2022
Initial Date FDA Received09/16/2022
Supplement Dates Manufacturer Received08/23/2022
Supplement Dates FDA Received11/11/2022
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age69 YR
Patient SexMale
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