MAUDE Adverse Event Report: MEDTRONIC IRELAND INTEGRITY RX; STENT, CORONARY

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

Patient Problems Cardiac Arrest (1762); Insufficient Information (4580)

Event Date 09/20/2021

Event Type  Injury  

Manufacturer Narrative

Journal article: outcome of ductus arteriosus stenting including vertical tubular and convoluted tortuous ducts with emphasis on technical considerations year: 2021.Ref: doi.Org/10.1186/s43044-021-00210-4.Date of event: date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article titled - outcome of ductus arteriosus stenting including vertical tubular and convoluted tortuous ducts with emphasis on technical considerations - was submitted for review.This study aimed to present the authors experience in patent ductus arteriosus (pda) stenting with some technical tips to overcome difficulties, especially in stenting tortuous or long tubular ducts.Short and mid-term outcomes of the procedure were also presented.This study included all patients with cyanotic congenital heart disease who underwent cardiac catheterization to stent the pda.Pd a stenting was attempted in 43 patients between january 2011 and december 2018.Three-fourths of the patients had difficult ductal morphology and origin.Using the seldinger technique, the femoral artery and vein were both accessed with a 4f sheath and a 5f sheath, respectively.Angiography was usually performed with a judkins¿ right or pigtail catheter, to determine the morphology, length, and diameter of the pda, the confluence of the pulmonary arteries (pas) and the presence of stenosis.Ducts were classified into 4 groups according to their origin, and this determined the technique and approach used for pda stenting.Once the catheter had been directed toward the pda, multiple coronary wires were used to cross and were deployed into the pas.The medtronic integrity bare-metal stent (bms) (38%), driver bms (5%) and resolute onyx drug-eluting stent (3%) were among the stents used during the procedures the remaining 56% of stents used were non-medtronic.One stent was used to cover the pda in 27 patients, two stents were used in 13, and three stents were used in 2 patients.After the procedure, all patients were kept ventilated for at least 6 hours and given enoxaparin and oral aspirin.It was further stated that pda stenting done in newborn babies with pulmonary atresia is challenging, most complications are usually related to the complexities of the associated anatomy and t he procedure itself.Successful pda stenting was achieved in 40 patients.Immediate outcomes included the following: in one patient in the study, the stent migrated to the branch pas, which caused cardiac arrest, that was recovered with cardiopulmonary resuscitation.The patient with the migrated stent had a convoluted highly tortuous pda and it was reported that there was no causal relationship between the device and the complication.The procedure failed in another patient with three overlapping stents.Both these patients were sent for surgical palliation.The third patient died before the wire was passed or the stent was placed.This procedure was performed, as an emergency, on a critically ill baby with severe acidosis who was transferred from another hospital.Other intra-op complications included a patient who was accidently extubated leading to respiratory arrest.After difficult re-intubation and stabilization, the procedure was completed with no in-hospital sequelae.Sudden transient desaturation with no stent obstruction was observed in two patients.One patient developed reperfusion injury due to excessive pulmonary over circulation.The median duration of hospital stay was 5 days, with 6 in-hospital mortalities occurring.One patient died due to acute stent thrombosis, two patients due to severe pneumonia, and three patients from fulminant sepsis.In-stent stenosis occurred in 5 patients.These patients were successfully managed with catheter-directed re-interventions only.Two patients required repeat stenting for restenosis, and another two required balloon dilatations only.Development of left pulmonary artery (lpa) stenosis after stenting was detected during cardiac catheterization in two patients.Partial or complete jailing of a branch pa was noted in some patients.It was reported that all complications which occurred in this study were not related to the instruments (bms ,or delivery systems) used for pda stenting.As is well understood, the tortuous pda and those associated with stenosis of branch pulmonary arteries carry high risk for failure of stenting and complications.

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: INTEGRITY RX
• Type of Device: STENT, CORONARY
• 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: 13542987
• MDR Text Key: 290051089
• Report Number: 9612164-2022-00644
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: P030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• 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?: No
• Date Manufacturer Received: 01/17/2022
• 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): Required Intervention
• Patient Age: 18 DA
• Patient Sex: Male
• Patient Weight: 3 KG