MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE ONYX RX; CORONARY DRUG-ELUTING STENT

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

Patient Problems Stenosis (2263); Obstruction/Occlusion (2422); Insufficient Information (4580)

Event Date 02/01/2023

Event Type  Injury  

Manufacturer Narrative

Title: pulmonary vein atresia: feasibility of initial recanalization attempts with subsequent follow-up authors: varun aggarwal, gary e.Stapleton, lindsay f.Eilers, srinath gowda, manish bansal, athar m.Qureshi, melissa k.Webb, asra khan, and henri justino journal name: current problems in cardiology year: 2023 reference: doi.Org/10.1016/j.Cpcardiol.2022.101463 a2: average age a3: majority gender b3: date of publication patient deaths were also included in the results of the journal article, however no causal link suggesting that the medtronic devices used in the patient cohort may have caused or contributed to the deaths was provided.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.

Event Description

A journal article was submitted for review titled "pulmonary vein atresia: feasibility of initial recanalization attempts with subsequent follow-up".The aim of this article was to describe the institutional single center outcomes of transcatheter recanalization/management for pulmonary vein atresia (pva).The study included all patients who had pva (congenital as well as post operative) and underwent cardiac catheterization from (b)(6) 1995 to (b)(6) 2019 with follow-up data collected through (b)(6)2020.A total of sixty patients with pva underwent cardiac catheterization for evaluation of pva during this time.The 60 patients in the cohort had a total of 99 atretic pulmonary veins.The index atretic vein was the only diseased pv in 7 of patients.Twenty-three patients had only 2 diseased pvs, of which 14 patients had one additional atretic pv.Nine patients had a stenotic pv.Thirty patients had 3 or more diseased pvs, with 16 of these patients having at least 2 atretic pvs.Pva recanalization was attempted in 34 of these patients and was successful in 24 cases in the initial attempt.The occluded pvs were typically recanalized from the left atrium toward the lung, or occasionally retrograde from the lung toward the left atrium via a collateral from an adjacent patent pulmonary vein.To align the catheter in the left atrium parallel to the atretic pulmonary vein, a combination of coaxial catheters was used, usually consisting of a non mdt 4 fr judkins right coronary catheter or non mdt 4 fr angled glide catheter inside a guide catheter such as a 5 or 6 fr launcher jr4 guide catheter.In some cases, when steep angles could not be achieved using this coaxial catheter combination (eg to approach right lower lobe pva) a non mdt deflectable sheath was used.In cases of repeated failed attempts to cross an atretic lesion using chronic total occlusion (cto) wires, radiofrequency energy was used.The decision to attempt recanalization as well as the recanalization method (using cto wires, radiofrequency energy, transseptal needle, or a combination of these methods) was at the discretion of the operator.Once the atretic lesion was recanalized, angioplasty was generally performed with incremental balloon size (e.G.2, 3, and 4 mm non-compliant balloons), with use of high inflation pressures (>20 atm) if necessary to abolish the waist before proceeding to larger balloon diameters.Non mdt cutting balloons were used in cases where high pressure balloon angioplasty was unable to abolish the waist prior to stent implantation.Angiography was performed after each angioplasty to ensure the absence of extravasation of contrast.The largest balloon used was generally no larger than the distal patent pv diameter.Post angioplasty, stent implantation was performed in most cases, at the operator¿s discretion.Three patients underwent balloon angioplasty alone and 20 patients received drug-eluting stents.All stents used in the procedures were second-generation drug eluting stents (des), and included the resolute onyx des which was used in 10 patients.The primary outcome for this study was the pv recanalization success rate.Secondary outcomes were death, reintervention, pulmonary vein patency at the subsequent catheterization and at the last available catheterization, as well as distal pulmonary vein diameter at the index and final catheterizations.Three patients had complications during the index attempted recanalization procedure.One patient had a pulmonary hemorrhage after u nsuccessful recanalization attempt with non mdt chronic total occlusion (cto) wires, which resolved spontaneously.One patient developed a pericardial effusion during a recanalization attempt using rf (ultimately successful) for which a percutaneous pericardiocentesis was performed and the drain was removed on the following day.Finally, one patient had injury in the adjacent pv which required no intervention.There were no procedural deaths or neurologic injuries.At the first follow-up catheterization, five patients were found to havedeveloped recurrent atresia of the previously recanalized pv.One of these three patients was successfully recanalized again at a subsequent catheterization.Ten patients had in-stent stenosis requiring balloon angioplasty of the initially recanalized vein.Four patients had widely patent stents not requiring intervention.At the final catheterization in our study period, 14 patients were noted to have ongoing patency of the initially recanalized pvs, 5 had confirmed recurrent atresia of the affected veins, and 4 patients were lost to follow up.Three patients had surgical repair for restenosis of the recanalized vein after the initial transcatheter recanalization procedure.Of the 3 surgical procedures, 2 were sutureless repairs with removal of the stents and 1 was excision of a fibrotic membrane around the previously placed stent with partial removal of the stent to relieve jailing of the adjacent right middle lobe pv.Twenty two of the twenty three patients had tra nscatheter reinterventions during the follow up period.In patients in whom the pv was successfully recanalized at the index catheterization the incidence of mortality was 9% as compared to 26.3% for patients where pv recanalization was not initially successful.

Manufacturer Narrative

Additional information: annex d code.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.

Manufacturer Narrative

Additional information: it was stated that there was no causal relationship between the medtronic launcher guide catheter and resolute onyx devices and any of the deaths or adverse events reported.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: RESOLUTE ONYX 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: 17015402
• MDR Text Key: 316196582
• Report Number: 9612164-2023-02256
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 05/27/2023
• Supplement Dates Manufacturer Received: 06/05/2023; 07/10/2023
• Supplement Dates FDA Received: 07/04/2023; 07/12/2023
• 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: 1 YR
• Patient Sex: Male