MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD WOVEN AORTIC ARCH; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number	HEWAA3010080810/1
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the product is available for investigation, it should be returned to intervascular for examination.The review of historical data indicated that no other similar complaint was reported for the same lot number.The device history records review concludes that there is 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 or Problem Description
Before surgery, when the customer opened the packaging, they found yellow stains on the surface of inner packing.The product was not used.Picture attached to the complaint form shows product still in inner and outer blisters.
Additional Manufacturer Narrative
(10/193) the involved product was returned to intervascular and was visually inspected by our quality assurance (qa) supervisor.Results are as follows: - "after manual peeling of the internal blister lid, it appears that yellowish aureoles are visible on the lid corresponding to the location of the product in the internal blister." - "there is no collagen excess on the external or internal surface of the product" the conclusions are that the product is not compliant with our list of standards for acceptation and rejection for packaging and that root cause is unclear but probably related to inappropriate storage conditions by logistic actors.(4315) no conclusion can be drawn on the exact origin of the defect.The conducted investigation suggests that the device was not defective at the time of manufacturing.However, the product, as it was returned to intervascular, does not conform to the specification.Therefore, a non-conformity report has been initiated in order to investigate the root cause and take appropriate corrective actions if necessary.
Event or Problem Description
See initial mfr report #1640201-2019-00091 complaint #(b)(4).

• Brand Name: INTERGARD WOVEN AORTIC ARCH
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 9426180
• Report Number: 1640201-2019-00091
• Device Sequence Number: 534151
• Product Code: DSY
• UDI-Device Identifier: 00384401010760
• UDI-Public: 00384401010760
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2020

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 Expiration Date: 02/28/2021
• Device Model Number: HEWAA3010080810/1
• Device Catalogue Number: HEWAA3010080810/1
• Device Lot Number: 16C24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1