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

Model Number	M00202175828P0 - PLATINUM WOVEN AORTIC ARCH 1B
Medical Device Problem Codes	Material Frayed (1262); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(4109/213) the review of historical data indicated that no other complaint was reported for the same sterilization lot number: 24k09.(3331/3233) a review of the device history records is ongoing, results are pending (10/3233) it was reported that the product is available for investigation, it should be returned to intervascular for examination.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
It was reported to intervascular that the graft was fraying upon attempt to sew into place, after being cut to size.Another graft was used to complete the case.Complaint#: (b)(4).
Additional Manufacturer Narrative
Corrected data: on block h1, "type of reportable event" has been updated from serious injury to malfunction.Following completion of the investigation, the fraying was determined to be most likely due to a use error, i.E.Cutting of the prosthesis with scissors, which deviates from the instructions for use.As the fraying was not caused by an intrinsic defect and did not lead to, nor could reasonably have led to, a serious deterioration of health, the event does not meet the mdr definition of a serious injury.The classification has therefore been updated to malfunction.Narrative: (3331/213) the device history records review concluded that there was no non conformance / planned deviation in relation with the event reported.(4110/213) the occurrence rate was calculated for similar events on the same product family (hemashield grafts and patches) for the period 01-nov-2024 to 31-oct-2025.The calculated occurrence rate is 0.001%, which is compliant with the requirement of being less than or equal to the anticipated maximum occurrence rate of 0,01%.(10/4248) two returned fragments of the involved device were visually inspected by the quality assurance (qa) engineer and concluded that the involved device is conform to the product specifications.One extremity, from the shortest fragment has visible loose threads and a beveled cut which is not aligned with the crimps, where the graft was cut by scissors as indicated by the user.(4111/4248) communication with the end user confirmed that there was no visual defect on the graft before use and that scissors were used to cut the graft.They indicated that there was a delay in surgery since they had to get another graft opened and that no further issues occured with the new product.(67/18) based on the investigation findings it is concluded that the loose threads observed on one extremity by the surgeon after cutting the graft are likely due to the use of scissors instead of a low temperature disposable cautery as indicated in the ifu.Indeed, as per instruction for use of hemashield platinum woven vascular grafts, due to their intrinsic weaving pattern, woven grafts are more prone to fraying.The warning section states that woven grafts should not cut with scissors or scalpels to limit the risk of graft fraying.In addition, the section directions for use of the ifu stated the following: ¿as with all the woven products, the hemashield platinum woven vascular grafts should be cut with a low temperature disposable cautery (e.G., 900°f / 500°c) to minimize fraying".
Event or Problem Description
Complaint # (b)(4).

• Brand Name: HEMASHIELD PLATINUM
• 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: clemence vaneenoge ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 23063288
• Report Number: 1640201-2025-0000024
• Device Sequence Number: 9866773
• Product Code: MAL
• UDI-Device Identifier: 00384401018575
• UDI-Public: (01)00384401018575
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K021213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2025

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: M00202175828P0 - PLATINUM WOVEN AORTIC ARCH 1B
• Device Catalogue Number: M00202175828P0
• Device Lot Number: 24K09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown