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

Model Number HEWAA2410080810/1 - INTERGARD WOVEN AORTIC ARCH

Device Problem Product Quality Problem (1506)

Patient Problem No Patient Involvement (2645)

Event Date 11/15/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that the product is available for investigation, it should be returned to intervascular for examination in the coming days.The review of historical data indicated that another similar complaint was reported for the same lot 17m07 and the same product reference.The second case comes from the same hospital (complaint #(b)(4)).The investigation is ongoing.The device history records review concluded that there is no non-conformance / planned deviation in relation with the event reported.Two retention samples were selected based on the following criteria: one was coming from the same sterilization lot and was coated on the same day and under similar conditions as the involved device of complaint (b)(4).One was coming from the same sterilization lot and was coated on the same day and under similar conditions as the involved device of complaint (b)(4).During the complaint investigation, these retention samples were visually inspected by the quality assurance supervisor, inspection of packaging components included.No stain was found on the internal and external primary packaging of the retention samples.The products and packaging are in compliance with specification.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

Complaint #(b)(4).When the doctor opened the outer packing, they found there was yellow dot on the inner packing.The event occurred before surgery.

Manufacturer Narrative

(10/193) the involved product was returned to intervascular and was inspected by our quality assurance (qa) supervisor.His observations are as follows: "the product arrived in its box but damaged.The external and internal lids were not open.There is a match between the product, the labelling of the box and the patient set.After manual peeling of the internal blister lid, it appears that yellow halos are visible on the lid corresponding to the location of the product in the internal blister.The product does not present any apparent collagen excess defect (collagen excess internal and external) according to our internal specifications.In addition, a visual inspection of the primary packaging, including the sealing strip, the shells and the lid, is performed on each packaged product with the criterion "stain embedded in the inner lid" as a defect standard, with an acceptability limit of < 0.2 mm² in accordance with internal specifications.If this stain was present during the primary packaging of this product it would have been rejected during the control of this packaging to be repackaged, we cannot therefore rule on the origin of the defect other than inadequate storage conditions by our various stakeholders." (11/213) as an additional investigation since the initial mdr, another retention sample was selected based on the following criteria: same sterilization lot, coated one day before the involved device of complaint (b)(4) and seven days before the involved device of complaint (b)(4).Product configuration closer than the previous retention samples selected for the initial mdr.This new selected retention sample was visually inspected by the quality assurance supervisor, including the control of packaging components.No stain was found on the internal and external primary packaging of the retention samples.The product and his packaging are in compliance with the specifications.(4109/193) the review of historical data indicated that one other similar complaint (#(b)(4)) was reported for the same lot 17m07 and the same product reference.The second case (complaint #(b)(4)) comes from the same hospital and has an identical logistical traceability.The visual inspection of the returned product for complaint #(b)(4)concluded that the product was also defective probably due to inappropriate storage conditions.Therefore, we can assume that both products are defective probably due to inappropriate storage conditions applied for these two products by the various stakeholders.(4308) the outcome of our investigation, which included all available information and the testing we performed, suggests that the returned graft was not defective at the time of manufacturing.The most probable cause of the defect is inadequate storage of the device by the various stakeholders.An internal non-conformity report has been initiated in order to investigate the root cause and take appropriate corrective actions if necessary.

Event Description

See initial mfr report #1640201-2020-00024 (complaint #(b)(4)).

• Brand Name: INTERGARD WOVEN AORTIC ARCH
• 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: 10984167
• MDR Text Key: 220723818
• Report Number: 1640201-2020-00024
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K013651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: HEWAA2410080810/1 - INTERGARD WOVEN AORTIC ARCH
• Device Catalogue Number: HEWAA2410080810/1
• Device Lot Number: 17M07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1