MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDEAVOR SPRINT RX; STENT, CORONARY, DRUG-ELUTING

Catalog Number ENSP35015X

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

Patient Problems Unspecified Infection (1930); Obstruction/Occlusion (2422); Pseudoaneurysm (2605); Thrombosis/Thrombus (4440)

Event Date 08/31/2019

Event Type  Injury  

Manufacturer Narrative

Journal article: right coronary artery pseudoaneurysm after drug-eluting stent: dilemma solved on dual-source computed tomography authors: vineeta ojha, kartik ganga, mumun sinha, and arun sharma journal: ann thorac surg year: 2020.Reference: doi.Org/10.1016/j.Athoracsur.2019.07.038.Date of event: date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted entitled ¿right coronary artery pseudoaneurysm after drug-eluting stent: dilemma solved on dual-source computed tomography" it was reported that a patient had two endeavor sprint rx zotarolimus-eluting stents implanted in the proximal (4 x 24mm) and distal (3.5 x 1.5mm) rca artery.Three years later the patient presented with intermittent fever for 2 months.A mass lesion involving the right ventricular outflow tract (rvot) was observed.Angiography revealed a giant peripherally thrombosed pseudoaneurysm arising from the proximal-most rca via a narrow neck.It was causing mass effect over the rvot.The stents were occluded.The distal rca was reformed from the lad.There were multiple nodular lesions in both lungs with tree in bud changes, suggestive of active infection.The study reported that giant coronary artery aneurysms are extremely rare.Causes can include delayed healing of endothelium, medial inflammation, and hypersensitivity reactions owing to antiproliferative agents from drug eluting stents in addition to the procedural trauma.It was indicated that the patient most likely had type iii pseudoaneurysm which is of infectious or mycotic ethology and could have developed because of denudation of the already-inflamed endothelium owing to bacteremia or superimposed infection.Management consists of optimal antibiotic cover and surgical excision of the sac with coronary artery bypass graft.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDEAVOR SPRINT RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 10874813
• MDR Text Key: 217336742
• Report Number: 9612164-2020-04527
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P060033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ENSP35015X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR