MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD; GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE

Model Number M00202175126P0 - PLATINUM WOVEN STRAIGHT

Device Problems Nonstandard Device (1420); Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2022

Event Type  malfunction  

Event Description

It was reported to intervascular that when the doctor opened the package before the surgery, some dark color pollution were found on the surface of the graft.He used another graft instead to complete the surgery.It was also indicated that the event occurred before the surgery and the surgery was not delayed complaint#: (b)(4).

Manufacturer Narrative

(3331/213) the device history records review concluded that there was no non-conformance / planned deviation in relation with the event reported.(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number: 22e11.(10/3233) it was reported that the product is available for investigation, it should be returned to intervascular for examination.(11/3233) one retention sample from same sterilization lot number was selected based on the same coating day and the same coating parameters as the involved device.A visual inspection will be performed.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Manufacturer Narrative

Corrected data: following device evaluation, device code 1506 in h6 is replaced by 1420.(10/170) the involved device was returned to intervascular for examination.A visual inspection performed by the quality assurance (qa) supervisor and quality assurance (qa) manager concluded that the biggest particle looks like a fiber placed on the graft.It is necessary to send the product for analysis to the external laboratory to have the particles identified.(10/3233) the product was sent to an external and independent laboratory for analysis.The results are pending.(11/213) one retention sample from same sterilization lot number was selected based on the same coating day and the same coating parameters as the involved device.A visual inspection performed by the qa supervisor concluded that the product is in compliance with the specification.No stain was observed on the retention sample as the event reported.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.Please note that a non-conformity report has been initiated in order to determine the root cause.

Event Description

Complaint #(b)(4).

Event Description

Complaint #(b)(4).

Manufacturer Narrative

(10/170) the product was sent to an external and independent laboratory for further analyses to characterize the identified particles.The report analysis concludes that : particles about approximatively 2,5 mm are iron-rich particles.These particles are partially covered by deposit (corrosion products, organic contamination?); brown stains are rich in iron but also in oxygen and carbon.Ftir analyses show the presence of the same compounds as on reference areas: glycerol and polypeptide (probably the collagen).Traces of polyester (textile) is also detected (less than on reference area).These brown stains could be corrosion products from the surrounded particles.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.Please note that a non-conformity report has been initiated in order to determine the root cause.

Manufacturer Narrative

(3331/170) a non-conformity report was opened in order to investigate and determine the root cause.A thorough investigation of the manufacturing process was conducted.The investigation report concluded that based on the findings of the investigation, it is not possible to conclude on the origin of the particles identified on the complaint product.Only one hypothesis related to quality control failure could provide an explanation.However, the width of the particle observed on the product makes this hypothesis very unlikely." based on the internal non-conformity investigation, this is an isolated event.(25) the investigation concluded that it was not possible to identify the exact origin of the involved product contamination during its manufacturing.However, the conducted investigation and testing performed suggest that this is an isolated event.

Event Description

Complaint #(b)(4).

• Brand Name: HEMASHIELD
• Type of Device: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
• 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: 16103058
• MDR Text Key: 308670028
• Report Number: 1640201-2023-00001
• Device Sequence Number: 1
• Product Code: MAL
• UDI-Device Identifier: 00384401018063
• UDI-Public: (01)00384401018063
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K021213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00202175126P0 - PLATINUM WOVEN STRAIGHT
• Device Catalogue Number: M00202175126P0
• Device Lot Number: 22E11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1