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

Model Number HGKUT0007-40

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Pseudoaneurysm (2605)

Event Date 10/25/2016

Event Type  Injury  

Event Description

It was reported to intervascular that a leakage vascular graft was observed after 2 years of implantation (2014 - 2016).The leaks were "repaired" with 2 stents, without explanting the graft.The graft was implanted in 2014, a fem-pop procedure was conducted.Complaint # (b)(4).

Manufacturer Narrative

The device is not accessible as it remained implanted in the patient.The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 14e05.The device history records review is ongoing the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

See mfg initial report#: 1640201-2022-00018 complaint#: (b)(4).Two (2) other adverse events were also reported jointly, all similar in nature and from a single user.See mfg reports: 1640201-2022-00019 (complaint#: (b)(4) and 1640201-2022-00017 (complaint#: (b)(4).

Manufacturer Narrative

Corrected data: on block h6, medical device ¿ problem code , code 3190 is replaced by code 2993.(3331/213) the device history records review concludes that there is no non-conformance / planned deviation in relation with the event reported.(4111/3221) the investigation involved communication with the surgeon who reported the event.However, no further information could be obtained about the event.Additional manufacturer narrative: all the available information related to the 3 pseudoaneurysms cases reported jointly by the same physician have been sent to the medical affairs whose assessment is as follows: "getinge received a series of (3) product complaints, all similar in nature from a single user.Each complaint describes the uneventful implantation of an intergard vascular graft for a femoral-popliteal bypass procedure and subsequently developed a pseudoaneurysm requiring endovascular surgical intervention.The bypass procedures occurred in 2012, 2014 and 2015 and the pseudoaneurysm was discovered 6 years, 2 years and 7 years, respectively, after implantation.In the complaints, there was no mention of the complexity of the fem-pop procedure or of any post-operative complications including symptoms such as pain, swelling, or infection.In each case, the location of the pseudoaneurysm is unknown and there is no diagnostic imagining available for review.The complainant states that in each case, the graft remained implanted and the pseudoaneurysm was repaired successfully using one or two covered stents.On further questioning, specifically regarding the complexity of the procedure as well as the vessel quality and location of the pseudoaneurysm, there was reluctance from the surgeon to provide any additional information.These answers may have helped to narrow down the potential cause of the pseudoaneurysm.Review of the device history records for the devices concluded that there was no non-conformance in relation to the event reported.Clinical literature reports that arterial pseudoaneurysm due to breakdown of surgical arterial anastomosis is a known complication of arterial bypass with vascular graft procedures.(1) the most common location for pseudoaneurysm is the common femoral artery to bypass graft junction, which occurs in 0.8-2.2% of revascularization procedures.(2).In conclusion, there is a lack of vital information to fully understand the cause of these 3 complaints of pseudoaneurysm.It is reasonable to assume that the formation of the pseudoaneurysm was due to due the breakdown of the anastomosis.All 3 patients required endovascular surgical intervention to repair the pseudoaneurysm.The devices in these complaints could not be investigated further as they remain implanted.References: (1).Jon c.Henry, md, ms, rpvi, fica, randall w.Franz, md, facs, rvt, rpvi, rica; pseudoaneurysms of the peripheral arteries; int j angiol 2019;28:20-24 (2).D.Baldwin, h.Mashbari, k.L.Chow, and m.Sarhan; ruptured superficial femoral artery anastomotic pseudoaneurysm after 30 years ¿ case report; published 22 july 2019." (4315) no conclusion can be drawn on the exact origin of the defect since the product remained implanted and limited information was provided by the reporter.However, the conducted investigation suggests that the device was not defective.The cause of the event is likely related to a known complication of the procedure.(22) to be noted that pseudoaneurysm is an expected undesirable side-effect as indicated in the product instructions for use.

• Brand Name: HEMAGARD KNITTED UT STRAIGHT
• 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: laurence richard ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 14688150
• MDR Text Key: 294542978
• Report Number: 2242352-2022-00528
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401014713
• UDI-Public: (01)00384401014713
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K983819
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: HGKUT0007-40
• Device Catalogue Number: HGKUT0007-40
• Device Lot Number: 14E15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/27/2022
• Distributor Facility Aware Date: 07/01/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2022
• Date Manufacturer Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/15/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male