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.

• Brand Name: ENDEAVOR SPRINT RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• 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
• Reporter Country Code: IN
• PMA/PMN Number: P060033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

0 Patients were 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

• Device Catalogue Number: ENSP35015X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial