MAUDE Adverse Event Report: VASCUTEK LTD. THORAFLEX HYBRID; THORAFLEX HYBRID ANTE-FLO

Model Number THORAFLEX HYBRID

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

Patient Problem Anemia (1706)

Event Date 12/14/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturers narrative clinical code : 1729 - anemia - event reported from study site as anemia.Impact code : 4648 - insufficient information - the site have stated patient has recovered with treatment , awaiting information on what treatment was performed.Medical device problem code: 2993- adverse event without identified device or use problem - no device deficiency has been reported.Component code: 4755 - part component / sub- assembly term not applicable - device has no component parts type of investigation 4109 - historical data analysis- 1 previous event of anemia reported in thoraflex hybrid devices (b)(6).4110 - trend analysis- a 5 year similar event review was performed for medical event>other (anemia) in thoraflex hybrid devices (b)(6).A similar event rate of (b)(4) was confirmed.4111- communication / interviews- further information has been requested on the treatment to resolve this issue.3331 - analysis of production records- review of all retained device records showed no issues.4114 - device not returned- device remains in -situ.

Event Description

Automated e-mail notification received from study database on (b)(6) 2024 reporting the event of acute post op anemia from (b)(6) 2023 the same day as the th was implanted.Information provided from site was - baseline (b)(6) 2023 hgb = 13.7 hct =40.6, intra op (b)(6) 2023 hgb= 6.2 hct= 19.This is still unresolved and not being treated.The subject remains in the study.An export of the information available in the study database for this subject to date has been provided separately.No surgical interventions.Transfusion given on (b)(6) 2023 2 units given.Also on ed admission given 2 units on (b)(6) 2023.The site have not completed the device deficiency ecrf.

Event Description

Automated e-mail notification received from study database on 02 january 2024 reporting the event of acute post op anemia from (b)(6) 2023 the same day as the th was implanted.Information provided from site was - baseline 11.23.2023 hgb = 13.7 hct =40.6, intra op 12.14.2023 hgb= 6.2 hct= 19.This is still unresolved and not being treated.The subject remains in the study.An export of the information available in the study database for this subject to date has been provided separately.No surgical interventions.Transfusion given on (b)(6) 2023 (b)(4) units given.Also on ed admission given (b)(4) units on 1.1.2023.The site have not completed the device deficiency ecrf this report is being submitted as follow up #1 for manufacturing report 9612515-2024-00003 to provide event closure information for (b)(4).

Manufacturer Narrative

Manufacturers narrative clinical code : 1729 - anemia - event reported from study site as anemia.Impact code : 4648 - insufficient information - the site have stated patient has recovered with treatment , awaiting information on what treatment was performed.Medical device problem code: 2993- adverse event without identified device or use problem - no device deficiency has been reported.Component code: 4755 - part component / sub- assembly term not applicable - device has no component parts type of investigation 4109 - historical data analysis- 1 previous event of anemia reported in thoraflex hybrid devices jan 19 - jan 24.4110 - trend analysis- a 5 year similar event review was performed for medical event>other (anemia) in thoraflex hybrid devices jan 19 - jan 24.A similar event rate of (b)(4) was confirmed.4111- communication / interviews- further information has been requested on the treatment to resolve this issue.3331 - analysis of production records- review of all retained device records showed no issues.4114 - device not returned- device remains in -situ.Investigation findings 213 - no device problem found - review of all retained manufacturing and quality records show the graft was manufactured to specification.Investigation conclusion 4315 - cause not established - further information was received from the site, anemia could be possibly related as drop in hgb/hct during operation.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: THORAFLEX HYBRID
• Type of Device: THORAFLEX HYBRID ANTE-FLO
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD.; newmains avenue; inchinnan business park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan business park; glasgow, renfrewshire PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 18604584
• MDR Text Key: 334023845
• Report Number: 9612515-2024-00003
• Device Sequence Number: 1
• Product Code: QSK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P2100006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: THORAFLEX HYBRID
• Device Catalogue Number: THA2830X150A
• Device Lot Number: 25191174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/09/2023
• 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): Other
• Patient Age: 45 YR
• Patient Sex: Female