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

Model Number HGKTP08/75CPUT (1)

Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

The device history records review concluded that there is no non-conformance / planned deviation in relation with the event reported.The review of post-marketing historical data indicated that no other similar complaint was reported for the same sterilization lot number 20k22.A retention sample from same lot, coated on the same day and with close coating parameters as the involved device was identified.This retention sample underwent water permeability testing.The test result indicated a value well within product specifications (< 5 ml/cm²/min).A fragment of the product involved was returned to intervascular and was sent to an approved independent laboratory for examination.The analysis report conclusion is: ¿the macroscopic analysis of the patch reveals no macroscopic defect in the textile structure which could predict haemostasis difficulties.¿ the investigation is still ongoing.A follow up report will be sent upon completion of the investigation.

Event Description

The complaint description we received is as follows: "continuous bleeding during the suture, lasting more than 150 min.This customer has a huge experience with our patches and it's the first time he has this problem." the following customer report was attached in the complaint file: "surgical intervention: mr.Xx, (b)(6) years old.The surgical intervention took place on (b)(6) 2021, and it was performed a left carotid endarterectomy with shunt.The patient was undergoing antiplatelet therapy with clopidogrel.Surgery was performed under general anesthesia with systemic intraoperative heparinization (50 mg).After patch suture with prolene 5/0 visiblack, and reversion with protamina 1:1, it was observed a persistent bleeding trough the patch pores.In that moment, it was added 30 mg more of protamine to try reversion.Very difficult hemostasis, in addition were used surgicel, tachocil for more than 150m.Finally, it was possible to reach local hemostasis.Closing suture with vycril and left with redón.We suspect a possible defect in patch tissue." additional information on the event and patient status was further received in the context of complaint investigation: currently, the patient evolves satisfactorily.The amount of blood loss is difficult to estimate, although it was not significant.The problem was to get haemostasis.The localization of the bleeding was in the penetration holes made by the needle and thread when sewing, also we observed it in the middle of the graft.Bleeding was diffuse.The patch is still implanted.It lasted approximately 2 hours to get haemostasis.Human fibrinogen and human thrombin were used to help achieve it.The customer had a piece of the material used.It has been sent to manufacturer for evaluation.

Event Description

See initial mfr report 1640201-2021-00006.Complaint (b)(4).

Manufacturer Narrative

Corrected data: in h6, following device evaluation, device code set as 1420 in the initial mdr is replaced by 2993.Additional manufacturer narrative: the case has been reviewed by our corporate medical officer on march 08th, 2021 based on the macroscopic device evaluation.At this step, a more detailed analysis (sem) was requested to confirm the absence of defect of the device, but the hypothesis that the event could be attributed to the patient pre-existing conditions was evoked.(4116/213) a complementary analysis by sem has been performed on the clinical sample (the remaining non-implanted fragment of the involved device) by a qualified external laboratory.The conclusion is: "when comparing the clinical sample with the control sample, no difference could be observed regarding the textile structure or the collagen layer integrity.The local crack observed results from the handling of the sample as the collagen layer had stiffened on the clinical sample.Non identified deposit traces (white on the sem figure) could be observed on the clinical sample, but with no potential influence on the permeability of the surface.A 50 m surface crater could be identified in one location of the control sample.However, the size of the crater is not large enough to induce any continuous leakage through the graft wall thickness.From these observations, one can conclude that the clinical sample is consequently not expected to leak more than the control sample.¿ following the sem analysis, the case has been reviewed again by our corporate medical officer on april 02nd, 2021.His assessment is as follows: ¿the bleeding described intraoperatively is compatible with what would be expected on a patient under chronic treatment with clopidogrel.The macroscopic and sem analysis performed on the specimen that was returned showed no evidence of anomalies in the structure and/or coating of the patch that could justify the profuse bleeding.Therefore the event appears to be connected to the pre-existing operative coagulation parameters of the patient.¿ (67) the conducted investigation suggests that the product was not defective.(4315) the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.However, the most probable root cause of the event could be attributed to the patient pre-existing conditions.(22) please note that bleeding is an undesirable side-effect as indicated in the instructions for use: "potential complication which may occur in conjunction with the use of any vascular prosthesis include thrombosis, embolic events, occlusion and stenosis, intimal hyperplasia which could cause recurrent symptoms, infection, sepsis, perigraft fluid, seroma, formation, bleeding, hematoma, fever, inflammatory reaction, pseudoaneurysm, anastomotic aneurysm, stroke, dilatation of the prosthesis, anastomotic disruption or tearing of the suture line and/ or host vessel." please note that it is also mentioned in the instructions for use: "considering how complex implantation of a vascular patch is and how many factors can influence the patient's condition, it is left to the surgeon to define the surgical technique, as well as the therapy to adopt before, during and after the procedure, and the appropriate follow-up".Occurrence of bleeding events is thoroughly monitored and reviewed by the manufacturer during monthly management meeting.During the last monthly review, bleeding trends on intergard/hemagard products showed values well below the maximum anticipated occurrence rate defined in the product risk assessment.

• Brand Name: HEMAGARD CAROTID PATCH KNITTED ULTRATHIN
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• MDR Report Key: 11380596
• MDR Text Key: 233737706
• Report Number: 2242352-2021-00189
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401015208
• UDI-Public: 00384401015208
• Combination Product (y/n): N
• PMA/PMN Number: K983819
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HGKTP08/75CPUT (1)
• Device Catalogue Number: HGKTP08/75CPUT (1)
• Device Lot Number: 20K22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2021
• Distributor Facility Aware Date: 03/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2021
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR