MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number UNK-CV-SR-VALIANT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Embolism (1829); Renal Failure (2041)

Event Date 09/11/2019

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information obtained from the journal article entitled: ¿expanded petticoat technique to promote the reduction of contrasted false lumen volume in patients with chronic type b aortic dissection¿ arkadiusz kazimierczak, md, phd, pawel rynio, md, phd, tomasz jedrzejczak, md, phd, krzysztof mokrzycki, dm, phd, rabih samad, md, phd, miroslaw brykczynski, md, anita rybicka, phd, labib zair, md, phd, and piotr gut owski, md https://doi.Org/10.1016/j.Jvs.2019.01.073.If information is provided in the future, a supplemental report will be issued.

Event Description

Talent stent graft systems were implanted in patients for the endovascular treatment of chronic type b dissections.The following adverse events were observed: acute renal failure, peripheral embolization, wound complications, interventional treatment.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information received; it was confirmed by the article author that no adverse event were noted as specifically related to any medtronic devices.It was confirmed that for the proximal thoracic device, a valiant freeflow stent graft device was used and a closed web tapered valiant stent graft was used medially with 5-10% oversizing in both areas.The endurant iliac extension used ranged from 16-20mm diameter and were 156mm in length.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 9556991
• MDR Text Key: 173923092
• Report Number: 9612164-2020-00101
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P070007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: UNK-CV-SR-VALIANT
• Device Catalogue Number: UNK-CV-SR-VALIANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 01/07/2020
• Supplement Dates Manufacturer Received: 01/09/2020; 01/09/2020
• Supplement Dates FDA Received: 01/23/2020; 01/23/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR