MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD WOVEN; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number IGW0030-15

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Unspecified Infection (1930)

Event Date 08/25/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).The importer mdr is submitted in addition to mfg mdr ((b)(4)), received and acknowledged by the fda on 10-oct-2019.The awareness date for the adverse event (death/serious injury) (b)(6) 2019.Please refer to parent record ((b)(4)) decision tree.

Event Description

Complaint of the customer : "based on internal observations and investigations, we suspect that the vascular prothesis intergard woven hemabridge has an increased infection rate.Today, we have reported this assumption to materiovigilance swissmedic." additional information received on 09/12/2019: as part of a cardiac surgery study on the cause of thoracic prosthesis infections, 50 patients with prosthetic infections and their possible causes were examined over a period of 5 years (2014-2019).It was found that out of 50 infections 25 patients had received an intergard prosthesis.Of the 25 affected patients, 6 deceased.The report is one in a series of 25 reports identified as (b)(6), all involving infection, six of which having resulted in patient death.

Event Description

Complaint of the customer : "based on internal observations and investigations, we suspect that the vascular prothesis intergard woven hemabridge has an increased infection rate.Today, we have reported this assumption to materiovigilance swissmedic." (corrected data) additional details following new information received on 23 oct 2019: as part of a cardiac surgery study, 23 prosthetics infections were analyzed on a period of 5 years and 9 months.22 patients were involved, including 5 deceases.This report is one of a series of 25 reports.

Manufacturer Narrative

Trackwise id # (b)(4).The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

Complaint of the customer: "based on internal observations and investigations, we suspect that the vascular prothesis intergard woven hemabridge has an increased infection rate.Today, we have reported this assumption to materiovigilance swissmedic." corrected data: following new information received on november 22nd and november 26th, 2019 : ¿ 23 cases of thoracic graft infection occurred with intergard woven on the period 2014-2019 in the hospital (early prosthetic vascular graft infection 14; late 9).22 patients were involved.¿ a prospective study (vascular graft cohort study - vasgra) was in progress in the hospital since 2013 ¿ the 23 cases of infection reported in the complaint of the customer are not all included in the vasgra study for several reasons (lack of patient consent, no fulfilment of inclusion criteria, etc¿).¿ among participants of the prospective study (n=435), 17 early prosthetic vascular graft infection were recorded and thereof 11 were from intergard, 4 from the competitor graft and 2 from mixed.This report concerns one of the 23 cases of thoracic graft infections.

Manufacturer Narrative

Corrected data: corrected following new information received from the hospital.(4112/ 213) an analysis of data provided by user was performed by our corporate medical officer.Here are the main results: -concerning the 23 infection cases: "in summary, the complaints data available is aligned with what is published in the literature and does not include any uncommon clinical information." -concerning the cardiac surgery study preliminary results: ¿the table shows a higher incidence of grafts¿ infections for the collagen coated grafts versus the gelatin coated.The percentage of both remains in within the expected incidence as mentioned by the investigators in the introduction of their study.Regarding the competitive graft used in the comparative group, it is unknown if it is used according to surgeon¿s preference or procedural preference.Both elements could add a significant bias to the group¿s analysis.It is not possible to comment further as no additional data has been shared regarding patients¿ demographics, comorbidities, procedural details and post-operative outcomes.¿ (22) risk review results: a review based on the risk management documentation combined with the clinical evaluation report and the ifu was performed.The conclusions are: -the actual occurrence rates are in accordance with the anticipated occurrence rates.-¿the mechanism of graft infection is well known and infection is a well-known risk associated with the use of vascular grafts¿.-¿infection is mentioned as an adverse effect on the ifu of intergard woven¿ (67) following completion of our investigation, it appears with the available information at this date that no unexpected infection rates have been reported and no product deficiencies have been demonstrated.Therefore, no specific action is taken.Nevertheless, we will continue to monitor infection trends monthly as required by our procedures to detect any further signals.We will also continue to periodically review the literature as required by our procedures to identify any recent publications relating to intervascular products or competitor devices to be sure any additional information that will become available will be handled on a timely manner.A new investigation will be performed in case of any alarming signal.

• Brand Name: INTERGARD WOVEN
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 9205049
• MDR Text Key: 162838315
• Report Number: 2242352-2019-01152
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/31/2021
• Device Model Number: IGW0030-15
• Device Catalogue Number: IGW0030-15
• Device Lot Number: 16D14
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2019
• Distributor Facility Aware Date: 11/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 63 YR
• Patient Weight: 81