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

Catalog Number ENSP30030X

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

Patient Problems Vascular Dissection (3160); Thrombosis/Thrombus (4440)

Event Date 11/30/2021

Event Type  Injury  

Event Description

A case study was submitted for review titled: optical coherence tomographic insights of very late stent thrombosis of a second-generation drug-eluting stent: a case report.During a procedure, three endeavor sprint drug eluting stents were implanted to treat a diffuse lesion in the right coronary artery (rca) which was causing critical stenosis.A 3.5 x 30 mm endeavor sprint was implanted in the proximal rca, a 3.0 x 30 mm endeavor sprint was implanted in the mid rca and a 2.75 x 30 mm endeavor sprint was implanted in the distal rca.The stents were implanted with an adequate overlap of stent edges.Post dilatation was performed with a 3.0 x 15 mm non-compliant (nc) balloon in the distal rca and a 3.5 x 15 mm nc balloon in mid-proximal rca and good angiographic results were achieved.The patient received dual antiplatelet therapy (dapt), including aspirin and clopidogrel, for 1-year post-pci, after which only aspirin was continued.Over 9 years after implantation of the three endeavor sprint stents, the patient presented with non-st elevation acute coronary syndrome.A coronary angiogram revealed diffuse in stent restenosis (isr) extending from proximal to the mid-stented segment of rca with a focal haziness causing 90% stenosis.This hazy lesion corresponded to the overlap segment of proximal-mid rca stents.An intracoronary optical coherence tomography (oct) imaging of rca was performed which revealed well-apposed struts throughout the length of the stented segment and also a diffuse intimal hyperplasia and neo-atherosclerosis which was causing a variable degree of luminal stenosis with maximal luminal area stenosis of 88% at one point.Fibrotic hyperplasia was noticed in the distal and proximal stent, neo-atheroma in the middle stent showed a predominantly lipid-rich plaque with minimal fibrous element, especially at the site of proximal stent overlap.This segment also revealed a thin overlying fibrous cap, plaque rupture and a white thrombus (very late stent thrombosis) causing significant luminal area reduction.The isr lesion was pre-dilated with a 2.5 x 15 mm semi-compliant balloon followed by a 3.0 x 15 mm nc balloon and a 3.5 x 15 mm nc balloon at high pressure.Oct imaging after the balloon angioplasty revealed a dissection flap at the upper edge of the proximal stent, extending from the neoatheroma.Oct images revealed a predominantly fibrotic plaque at this site.The diseased segment was treated with a 3.5 x 38 mm non mdt stent which was followed by high pressure (18 atm) post-dilatation with a 3.5 x 12 mm nc balloon.Repeat oct imaging revealed the non mdt stent was malposed at the proximal part.This segment was further post-dilated with a 4.5 mm nc balloon at 14 atm.The final post-pci angiogram showed thrombolysis in myocardial infarction iii flow and no residual stenosis.The patient was discharged on medication and on dapt.At the 6 month follow up, the patient was doing well.

Manufacturer Narrative

Title: optical coherence tomographic insights of very late stent thrombosis of a second-generation drug-eluting stent: a case report authors: parminder singh otaal, atit a.Gawalkar, and ajay shunmugarajan journal: european heart journal issue: 5 ref: doi.Org/10.1093/ehjcr/ytab490.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: procedural images in the article provided the basis of the analysis.The images provided confirm the reported thrombus, injury, intimal dissection and stenosis events.Annex d code added.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: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14140399
• MDR Text Key: 289490388
• Report Number: 9612164-2022-01495
• 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,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

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 Catalogue Number: ENSP30030X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 06/08/2022
• Supplement Dates FDA Received: 06/09/2022
• 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): Other; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male