MAUDE Adverse Event Report: INTERVASCULAR SAS HEMAGARD CAROTID KNITTED; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number	HGKTP08/75CP (1)
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Thrombosis/Thrombus (4440); Insufficient Information (4580)
Date of Event	02/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if the product is available for investigation.More information is being requested to the initial reporter in order to investigate and identify the root cause.The device history records review concluded that there was no non-conformance / planned deviation in relation with the event reported.The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 21k14.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
The following event was reported a hemargard patch that was implanted on the carotid artery.Customer claims there was clotting issues, and was concerned it was due to the patch.Complaint # (b)(4).
Additional Manufacturer Narrative
(4111/3221 several e-mail attempts were sent to the initial reporter to obtain more information on the event in order to investigate and identify the root cause.No response was received from the initial reporter.(4112) the case description was reviewed by the medical affairs whose assessment is below: "this event is described as a hemagard patch used for a carotid artery surgical procedure.The report states that there was a clotting issue, however, it was not described in any detail.It is unknown if the clotting or lack of clotting (ie oozing or bleeding) occurred during or after the procedure was completed, and how the issue was resolved.There is no mention of if the patch remained implanted or if it needed to be replaced.There is no information on file regarding the patient¿s past medical history, including any coagulation disorder or medications taken.The coagulation parameters pre- and intra- operatively are also unknown.It is also unknown what anticoagulation therapy the patient received during the procedure.The disposition of the patient post-operatively is unknown as well as if there was any harm to the patient in this case.Because of the extremely limited information provided, the complaint of ¿clotting issue¿ itself is not well understood, and it is impossible to conclude if the issue was a result of the hemagard patch or due to other factors." (11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
See mfg initial report 1640201-2022-00008.Complaint (b)(4).
Event or Problem Description
Complaint #(b)(4).
Additional Manufacturer Narrative
Corrected data : on block h6 medical device - problem code: the code 3190 was updated to 3191, as the event information received does not permit to classify the event.And no information will be received to classify it.On block h6 health effect - clinical code : the code "4580" was updated to "1888" and "4440", due to the extremely limited information provided for the ¿clotting issue¿, it is not well understood, it is unknown if it is about clotting linked to an excessive coagulation or a lack of clotting linked to an oozing or bleeding.Therefore two codes were selected.Additional manufacturer narrative : (10/213) the involved device was returned to an external and independent laboratory for examination on 9-may-2022.A macroscopic analysis has been performed, it concluded that : "the macroscopic analysis of the patch does not reveal any macroscopic degradation on the pet structure.It would have been interesting to perform a permeability test on this segment however, the sample was already in contact with blood and might be too small to be tested in our laboratory".The macroscopic analysis report was sent to the medical department updates the medical review.Below the conclusion : "an independent laboratory analysis of the implanted/explanted hemagard vascular (carotid) patch did not reveal a degradation of the pet patch.It was not possible to perform a permeability study due to the presence of blood throughout the patch.No further conclusions can be made regarding the cause of the ¿clotting¿ issue in this incident." (4315) based on the medical review and on the investigation conclusion, it is impossible to conclude if the issue was a result of the hemagard patch or due to other factors because of the extremely limited information provided.Indeed the complaint of ¿clotting issue¿ itself is not well understood, it is unknown if it is about clotting linked to an excessive coagulation or a lack of clotting linked to an oozing or bleeding.No conclusion can be drawn on the exact origin of the adverse event due to the lack of information and the fact that the defect could not be reproduced/confirmed through the analysis of a retention sample.However, the conducted investigation suggests that the product was not defective at the time of manufacturing.

• Brand Name: HEMAGARD CAROTID KNITTED
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer (Section G): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer Contact: laurence richard ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 13830598
• Report Number: 2242352-2022-00249
• Device Sequence Number: 19050093
• Product Code: DSY
• UDI-Device Identifier: 00384401015185
• UDI-Public: (01)00384401015185
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K964625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Importer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2022
• Report Date (Section F): 06/30/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: HGKTP08/75CP (1)
• Device Catalogue Number: HGKTP08/75CP (1)
• Device Lot Number: 21K14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/07/2022; 06/07/2022
• Initial Report FDA Received Date: 03/20/2022
• Supplement Report FDA Received Date: 05/05/2022; 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Date Report Sent to FDA: 06/30/2022