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

Model Number M00202175426P0

Device Problem Product Quality Problem (1506)

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

Event Date 09/14/2022

Event Type  malfunction  

Event Description

It was reporting to intervascular that while preparing for the aortic dissection surgery, a discolored area was discovered with melted collagen in the product.The operation was completed with another product of the same model stocked in the hospital.Complaint #: (b)(4).Please note that this complaint is one of a series of two complaints, the second complaint #: (b)(4) is also the subject of an initial emdr reporting.

Manufacturer Narrative

The involved device was returned to intervascular for examination.A visual inspection is pending.The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 21f02.The device history records review concluded that there was no non-conformance/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 Description

Complaint # (b)(4).

Manufacturer Narrative

(10/213) the involved device was returned to intervascular on 27-sept-2022 for examination.A visual inspection by a qualified quality control technician was performed, the conclusion is as follow: "- no identified default; - no lack of collagen; - identification of white and yellow stains in relation with the collagen." (67) the conducted investigation concludes that the product was conform to the specification.

• Brand Name: HEMASHIELD PLATINUM WOVEN STRAIGHT
• 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: laurence richard ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 15560161
• MDR Text Key: 301513319
• Report Number: 1640201-2022-00029
• Device Sequence Number: 1
• Product Code: MAL
• UDI-Device Identifier: 00384401018230
• UDI-Public: (01)00384401018230
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K021213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00202175426P0
• Device Catalogue Number: M00202175426P0
• Device Lot Number: 21F02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose