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

Device Problem Material Distortion (2977)

Patient Problems Intimal Dissection (1333); Thrombus (2101)

Event Date 10/15/2009

Event Type  Injury  

Event Description

This study investigated the vascular response in early period after endeavor sprint implantation using optical coherence tomography (oct).A total of 31 zes in 30 patients underwent serial oct at immediate post-intervention and 3 months.Neointimal growth and malapposition were analyzed at each stent strut of cross-sectional oct images with 0.5-mm intervals.The incidence of malapposition at post-intervention and 3 months was 6.0% and 0.2%, respectively.However, late acquired malapposition was not detected at 3 months.Of 31 stents, 27 stents (87.1%) were covered completely with neointima, but the remaining 4 stents had 2 (0.8%), 4 (0.9%), 4 (1.2%), and 6 (1.4%) uncovered struts.Overall mean percentage of covered stent struts was approximately 99.9%.This finding was consistent among groups with acute coronary syndrome and stable angina pectoris.Intracoronary thrombus was documented in 1 stent (3.2%) among 31 stents.Stent edge dissection was detected in 14 lesions (45.2%) at the post-intervention but completely disappeared.On oct examination after 3 months.Thrombus was detected in 1 stent (3.2%) at 3 months, although it was visible in 11 stents (35.5%) at post- intervention.At 3 months, target vessel revascularization occurred in 2 patients.This study concluded that the most of the stent struts were covered with neointima, and late acquired malapposition was not found at 3 months after zes implantation.The study reported to demonstrate that endeavor sprint rx might have a favorable in vivo vascular response at 3 months after stent implantation.

Manufacturer Narrative

Evaluation results: unknown (no device returned).Inherent risk of procedure (material distortion, dissection, thrombus, restenosis of the stented artery).Unable to confirm complaint (no device returned).Conclusion results: inherent risk of procedure (material distortion, dissection, thrombus, restenosis of the stented artery).Unable to confirm complaint (no device returned).Unknown - (no device received for analysis).(b)(4).The information could not be matched with other information known to medtronic.Attempts made to obtain additional details.Date of event ¿ date manuscript accepted j am coll cardiol intv 2009;2:1240 ¿7) 2009 by the american college of cardiology foundation.Volume 2, no.12, 2009 issn 1936-8798/09 ¿evaluation of zotarolimus eluting stent at 3 months using optical coherence tomography¿ [endeavor oct].

• Brand Name: ENDEAVOR SPRINT RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 3766778
• MDR Text Key: 4380602
• Report Number: 9612164-2014-00438
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P060033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2014
• 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
• Treatment: ASPIRIN, CLOPIDOGREL
• Patient Outcome(s): Required Intervention
• Patient Age: 00062 YR