MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD PLATINUM WOVEN AORTIC ARCH 4B; GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE

Model Number	M00202175928P0
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The involved device was returned to an intervascular for examination.A visual inspection by the qa department is pending.The review of historical data indicated that no other similar complaint was reported for the same lot number.The device history records review concluded that there was no nonconformance / planned deviation in relation with the event reported.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
It was reported that: " professor (b)(6) of thoracic surgery, (b)(6) medical center, (b)(6) hospital while preparing for surgery, stains were found on the graft, so it was not used." no adverse event was reported, the surgery was not delayed.Complaint #(b)(4).
Additional Manufacturer Narrative
(10/213) a visual inspection of the involved product was performed by the quality assurance (qa) manager on 17-march-2022.His conclusion is as follows: the product has slightly more yellow areas on the outside of the denture.This is collagen that has yellowed over time.Note that at the time of qc, the collagen is white/translucent as a reminder, the products are rather white when they leave our production lines and turn yellow with sterilization and time.The products at the end of their expiration date are of a stronger yellow color without impact on the product performance.I suggest that the product be reviewed by the quality control (qc) cfm2 team to assess the compliance of the product.In my opinion, there is no excess thickness.The involved product was visually inspected on 22-march-2022 by a qc technician.His conclusion is as follows: there is nothing wrong with it, the collagen does not go beyond the crimps and there are no big clumps.(67) the conducted investigation concluded that the product was not defective.Please note that the color of hemashield products changes over time.The products are rather white when they leave the manufacturing lines and turn yellow with sterilization and over time.Products approaching the end of their shelf life are a deeper yellow color, with no impact on product performance.
Event or Problem Description
Complaint (b)(4).

• Brand Name: HEMASHIELD PLATINUM WOVEN AORTIC ARCH 4B
• Common Device Name: 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: laurence richard ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 13658022
• Report Number: 1640201-2022-00006
• Device Sequence Number: 11239219
• Product Code: MAL
• UDI-Device Identifier: 00384401018650
• UDI-Public: (01)00384401018650
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K021213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00202175928P0
• Device Catalogue Number: M00202175928P0
• Device Lot Number: 21A27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose