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

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

Patient Problem Hematoma (1884)

Event Type  Injury  

Event Description

This complaint was opened following literature review.The article is titled "patch angioplasty during carotid endarterectomy using different materials has similar clinical outcomes" by liesker et al.Doi: https://doi.Org/10.1016/j.Jvs.2022.09.027.The aim of the study was to compare the long-term follow-up outcomes in patients who underwent carotid endarterectomy (cea) and closure with either a bovine pericardial patch (bpp) or polyester patch.The study concerns 417 cea patients; 254 patients (61%) received a bpp and 163 received (39%) a polyester patch.The study demonstrated that significantly fewer bpp patients has short-term (#30 days) cervical hematoma compared with polyester patch patients (p =.047) (n= 9).Polyester patch patients received hemagard carotid patches.The exact reference of the used patch is unknown.On average, in the polyester patch group, the age was 71.2 years, 68% were male and the bmi was 27.5 kg/m².

Manufacturer Narrative

Mfg narrative: block b3 was left empty as this case was opened following literature review from an article with a broad time frame.Indeed, the retrospective cohort study was conducted including all patients who underwent primary cea and closure with a bpp or a polyester patch between january 2010 and december 2020 at the referral center.(4117) the devices are not accessible for testing as they remained implanted in the patients.(4111/3221) a letter was sent to the author of article "patch angioplasty during carotid endarterectomy using different materials has similar clinical outcomes" submitted to the society for vascular surgery, volume 77, issue 2 (2023) in order to obtain more information on the reported cases and the involved products.No additional information was obtained from the author as he indicated that he is not allowed to provide information to third parties.In view of the lack of information on the product references cited in this article, no further investigation can be conducted.(4112/3233) a medical assessment of the reported cases is currently ongoing.(11) a follow-up report will be sent upon completion of the medical assessment.Article citation: liesker, david.¿ patch angioplasty during carotid endarterectomy using different materials has similar clinical outcomes¿ society for vascular surgery, volume 77 issue 2 february 2023, p559-566.E1, https://doi.Org/10.1016/j.Jvs.2022.09.027 h3 other text : 4117 - the patches remained implanted.

Event Description

Complaint#: (b)(4).

Manufacturer Narrative

(4112/213) the article has been reviewed by the medical affairs department whose assessment is below: "this medical report pertains to cases discussed in an article published in the journal of vascular surgery authored by david j.Liesker et al in february 2023.The study in question is a retrospective cohort study conducted at a single center, involving 417 patients who underwent carotid endarterectomy.Among the 417 patients, 254 (61%) were treated with a bovine pericardial patch, while 163 (39%) received a polyester patch (hemagard carotid patch, unspecified model number).Notably, patients who received the bovine patch underwent surgery between 2015 and 2020, whereas those implanted with the polyester patch primarily underwent surgery between 2010 and 2015.However, the study does not provide information regarding the number of surgeons involved or the specific timeframe of their involvement.The hemagard complications observed in this study are as follows: short -term adverse outcomes (<30 days): 1.Wound infection (2 cases), 2.Cervical hematoma (9 cases), 3.Restenosis (2 cases), 4.Transient ischemic attack (tia) or cerebrovascular accident (cva) (10 cases), 5.Mortality (2 cases), long-term complications: 1.Patch infection (3 cases), 2.Reintervention (13 cases).The complaints team reached out to the author to request additional patient information, but the author was unable to provide any further details.The results presented in this publication appear to be consistent with the complications described in the literature for carotid endarterectomy.Due to the absence of patient-specific data and detailed information about each surgical procedure, a comprehensive investigation of the reported complications is not possible.It is worth noting that dr.Liesker received support from an unrestricted grant provided by lemaitre vascular, the manufacturer of xenosure, the biologic vascular patch employed in this study." (22) to be noted that hematoma is an undesirable side-effect as indicated in the current product instructions for use.Moreover, the medical affairs department underlines that the results presented in the publication appear to be consistent with the complications described in the literature for carotid endarterectomy.Due to the absence of patient-specific data and detailed information about each surgical procedure, a comprehensive investigation of the reported complications is not possible.

• Brand Name: HEMAGARD CAROTID KNITTED
• 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
• Manufacturer (Section G): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer Contact: clemence vaneenoge ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 17471407
• MDR Text Key: 320515805
• Report Number: 2242352-2023-00662
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2023
• Distributor Facility Aware Date: 09/05/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 09/05/2023
• Supplement Dates FDA Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other