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

Model Number	M00202175424P0
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	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to intervascular from the health facility that during a surgical procedure, a disintegration of the prosthesis occurred while suturing.It was described as a fraying.Another prosthesis was used to complete the surgery.Complaint #(b)(4).
Additional Manufacturer Narrative
(4109/213) the review of historical data indicated that no other complaint was reported for the same sterilization lot number 24l20.(3331/3233) a review of the device history records is ongoing, results are pending.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
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 an 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.(4112/4248) the case and its investigation have been reviewed by the medical affairs department who concluded that:"as made clear in the ifu, hemashield platinum woven double velour vascular graft should be cut to the size required with cautery, not with scissors at described by the surgeon.The surgical technique utilized may have been the cause of the procedural delay." (4110/213) the occurrence rate was calculated for similar events on the same product family (hemashield graft and patch) for the period 01-nov-2024 to 31-oct-2025.The calculated occurrence rate is (b)(4), which is below the anticipated occurrence rate (maximum) of (b)(4).(10/213) the involved device which was contaminated was sent to an external and independent laboratory for examination, macroscopic analysis did not reveal any macroscopic defects in textile structure.One thread was observed out of the structure at one extremity 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 the use of scissors to cut the graft.It was also indicated that the prosthesis was stored in its primary and secondary packaging in a temperature-controlled room (< 25°c) where the implantable medical devices are stored, near the operating rooms.The incident did not cause any major delay.The prosthesis came unstitched as soon as the first anastomosis threads were passed.The surgeon changed the prosthesis, reportedly, it took 5 minutes at the most.(18) based on the investigation findings the probable cause of the event is related to the cutting of the prosthesis with scissors.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 WOVEN STRAIGHT
• 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: 23017190
• Report Number: 1640201-2025-0000023
• Device Sequence Number: 13203723
• Product Code: MAL
• UDI-Device Identifier: 00384401018223
• UDI-Public: (01)00384401018223
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00202175424P0
• Device Catalogue Number: M00202175424P0
• Device Lot Number: 24L20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 62 KG