MAUDE Adverse Event Report: MEDTRONIC MEXICO SPRINTER OTW; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,

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

Patient Problems Myocardial Infarction (1969); Vascular Dissection (3160)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

Journal article: the pregnancy-associated spontaneous coronary artery dissection in a young woman with a novel missense mutation in notch1: a case report authors: bo bai, meng zhang, yihao zhuang, jirong zhu, wenjing li, wei ma and haibo chen journal: bmc medical genetics year: 2020 reference: doi.Org/10.1186/s12881-020-01058-2.If information is provided in the future, a supplemental report will be issued.

Event Description

A case report titled - the pregnancy-associated spontaneous coronary artery dissection in a young woman with a novel missense mutation in notch1: a case report - was submitted for review.The patient suffered from sustained chest pain in the early postpartum period.Ecg showed the st-segment elevation.Stemi was diagnosed.Coronary angiogram revealed the presence of long diffuse stenosis from ostium to distal end of lad with thrombolysis in myocardial infarction (timi) flow 3.It was noted that there was contrast hold-up near to mid-segments of lad which was likely attributable to spontaneous coronary artery dissection (scad), coronary vasculitis, or intramural hematoma.During a percutaneous coronary intervention (pci) procedure a non-medtronic guide wire was used to cross the lad to the distal end.A sprinter otw balloon catheter (pli10) was used to treat the proximal-middle lad at low pressure dilatation.The patient also received dual-antiplatelet and antithrombotic therapies.Three days later, the patient re-experienced intense chest pain and sweating.Ecg indicated acute myocardial infarction (mi) in the inferior wall and right ventricle.Coronary angiogram demonstrated the scad in the ostium of the right coronary artery (rca) with timi flow 1.The intravascular ultrasound (ivus) showed the artery dissection starting from proximal rca.Medication was administered and the patient underwent a second pci during which a non-medtronic guide wire was used to cross the rca to the distal end and pre-dilations by a sprinter otw balloon catheter (pli20) were performed at proximal-to-mid rca.Multiple drug eluting stents were implanted from distal to proximal segments and the ostium of rca.Three days after the second pci, the patient suffered from mi again.Coronary angiogram demonstrated long diffuse stenosis in lad and lcx.Ivus showed that multiple artery dissections located in mid to-distal segments of the left main coronary artery (lmc), lad, as well as the ostium and proximal segment of lcx.Multiple drug-eluting stents were positioned and implanted into focal lesions of lad, lcx, and lmc arteries to seal intimal tears.Antiplatelet and antithrombotic therapies were continued.The patient recovered and was discharged home.One month after discharge, follow-up at the outpatient department showed she had no chest discomfort.

Manufacturer Narrative

Additional information: annex d, annex g 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: SPRINTER OTW
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 11436030
• MDR Text Key: 239791415
• Report Number: 9612164-2021-00912
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: P790017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 30 YR