MAUDE Adverse Event Report: INTERVASCULAR SAS STANDARD; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number INTERGARD WOVEN AORTIC ARCH

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(3331/213) a review of the complaint device history records, indicated that the graft was processed and inspected according to established procedures and was therefore released following acceptable quality inspections and tests.These tests include a 100% inner diameter measurement based on the international iso (b)(4) standard for vascular grafts.(4109/213) the review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number.(10/213) a fragment of the involved product was returned to intervascular and was inspected by the quality assurance (qa) manager.His observations are as follows: "the sample was packaged in a pill box.The measurement of the sample diameter of the product body was performed with the qa measurement set no.1 mes 12-078 the result was: 26.8mm for a specification of 26mm +/- 1mm.From a diameter perspective, the transmitted sample conforms to the specification." (67) the conducted investigation suggests that the product was not defective.

Event Description

According to the surgeon, the diameter of the prosthesis is not the one indicated on the packaging.It was later confirmed that the graft was implanted.The surgeon cut a piece of the graft and sent it to us for evaluation.

• Brand Name: STANDARD
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• Manufacturer (Section G): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• Manufacturer Contact: zone industrielle athelia i; la ciotat
• MDR Report Key: 8873275
• MDR Text Key: 212174196
• Report Number: 1640201-2019-00037
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401010746
• UDI-Public: 00384401010746
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K013651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/08/2019

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
• Device Operator: No Information
• Device Expiration Date: 10/31/2023
• Device Model Number: INTERGARD WOVEN AORTIC ARCH
• Device Catalogue Number: HEWAA2610080810/1
• Device Lot Number: 18L01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 08/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1