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

Model Number	IGW0026-30
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2020
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 device history records review concludes that there is no non-conformance / planned deviation in relation with the event reported.One retention sample from same lot and coated on the same day and under the same conditions as the involved device was visually inspected by an experienced quality control technician.No defects in connection with a collagen peel-off was found, the product is conform to the specifications.The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
The graft was meant to be used to operate an aneurysm and after opening the product there was a problem of collagen peel-off.The product was not used.The surgery was not delayed.
Additional Manufacturer Narrative
Additional narrative: the case has been reviewed by our corporate medical officer.His assessment is as follows: ¿the patients history and procedural details are described in the [article].The assessment regards the findings of a 14 mm hemashield dacron graft used to perform a bypass between the ascending [aorta and the] descending thoracic aorta after over ten years of being implanted.The patient became symptomatic and a ct angiography was performed.The dacron graft resulted tortuous, calcified and severely stenotic at its distal portion near the anastomosis to the descending aorta.The pathologic changes identified are compatible with the use of this graft in this particular extra-anatomical location and with the duration of the implant.The lesions were addressed using several self-expandable stents post-dilated to 14 mm.The correction was successful and the patient had an uneventful recovery.¿ (4111/3221) the investigation involved a communication with the author.However, despite three attempts to obtain additional information on the product, event and patient, no additional information was obtained.(3331/3221) no graft identification was provided despite attempts to contact the author of the article.Therefore, no review of the device history records can be performed and therefore no results will be obtained.(4109/3221) no lot number was provided despite attempts to contact the author of the article.Therefore, the analysis of historical data concerning the same lot number cannot be performed and therefore no results will be obtained.Based on the following part of the assessment of our corporate medical officer ¿the pathologic changes identified are compatible with the use of this graft in this particular extra-anatomical location and with the duration of the implant¿ we conclude that it is a known inherent risk of device.Please note that, as indicated in the last approved version of the product instructions for use: ¿potential complications which may occur in conjunction with the use of any vascular prosthesis include thrombosis, embolic events, occlusion and stenosis, intimal hyperplasia which could cause recurrent symptoms, infection, sepsis, perigraft fluid, seroma formation, bleeding, hematoma, fever, inflammatory reaction, pseudoaneurysm, anastomotic aneurysm, stroke, dilatation of the prosthesis, anastomotic disruption or tearing of the suture line and/or host vessel¿.
Event or Problem Description
Device 1 of 2.Reference mfr.Report#: (b)(4).Follow-up revealed the patient's issue resolved over time.

• Brand Name: INTERGARD WOVEN STRAIGHT
• 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: 10586989
• Report Number: 1640201-2020-00019
• Device Sequence Number: 3143938
• Product Code: DSY
• UDI-Device Identifier: 00384401000228
• UDI-Public: 00384401000228
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K984294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

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: 12/31/2021
• Device Model Number: IGW0026-30
• Device Catalogue Number: IGW0026-30
• Device Lot Number: 17A12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1