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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERGARD WOVEN; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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INTERGARD WOVEN; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER Back to Search Results
Model Number IGW0028-15
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 01/09/2018
Event Type  Injury  
Manufacturer Narrative
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.(4117) device is not accessible for testing as it remained implanted in the patient.(4109/3233) the review of historical data is ongoing, results are pending.(3331/3221) no graft identification is available.Therefore, no review of the device history records can be performed.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.Device is not accessible for testing as it remained implanted in the patient.
 
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 (b)(6) 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.
 
Manufacturer Narrative
Corrected data: block b5 is corrected following new information received from the hospital.Additional manufacturer narrative: (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.
 
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 (b)(4)." 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.
 
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 prosthetic 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
(4109/213) the review of historical data done on the category intergard standard from january 2014 to september 2019 indicated that no other similar complaints for infection was reported for the same product configuration (woven graft) and that there is no similar complaints for infection on the same sterilization lot.(this series of 23 prosthetic infections excluded) (3331/213) the device history records review concludes that there is no non-conformance / planned deviation in relation with the event reported.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
 
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Brand Name
INTERGARD WOVEN
Type of Device
PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
MDR Report Key9141944
MDR Text Key161412439
Report Number1640201-2019-00068
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
PMA/PMN Number
K984294
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 12/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date05/31/2022
Device Model NumberIGW0028-15
Device Catalogue NumberIGW0028-15
Device Lot Number17F29
Was Device Available for Evaluation? No
Date Manufacturer Received11/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age51 YR
Patient Weight108
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