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

Catalog Number RONYX35030X

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Angina (1710)

Event Date 01/11/2022

Event Type  Injury  

Event Description

A case study was submitted for review titled ¿successful shockwave intravascular lithotripsy of an under-expanded stent after a month from primary implantation¿.During the index procedure, coronary angiography revealed critical stenosis in the right coronary artery (rca) and an additional lesion in the left circumflex artery (lcx).Percutaneous coronary intervention (pci) to the rca was successfully performed with 3.0x30 mm drug-eluting stent (des) implantation.Due to ongoing ischemia, the lcx was pre-dilated with a 2.0x15 mm non-compliant (nc) balloon at 12 atm and was followed by implantation of a 3.5x30 mm resolute onyx des at 16 atm.Due to significant stent under-expansion, optimization with a 3.5x15 mm nc balloon at 22 atm was performed however it was unsuccessful with significant ¿dog bone effect¿ observed.Additional post-dilatation was performed with an ultra-high-pressure 3.5x10 mm non-medtronic (mdt) nc balloon at 35 atm.Despite aggressive post-dilatation, full stent expansion was not obtained.The patient was discharged with symptoms of angina, class ii.One month later, the presented with exacerbation of angina symptoms (ccs class iii).Coronary angiography and fluoroscopic digital stent enhancement (dse) revealed incomplete stent expansion in lcx with a residual stenosis of 80%.Additional evaluation in optical coherence tomography (oct) revealed massive calcifications with co-existing impaired endothelialization on the under-expanded struts.Initially, post-dilatation was performed with a 3.5x15 mm nc balloon at 20 atm but this was unsuccessful.A non-mdt 3.5x12 mm intravascular lithotripsy (s-ivl) balloon was then used and after 40 ultrasonic pulses, full scaffold expansion was achieved.The stent was optimized with a 3.75x15 mm nc balloon at 16 atm.Coronary angiography, fluoroscopic digital stent enhancement and optical coherence tomography confirmed adequate stent expansion without any residual stenosis.The patient was discharged two days after the procedure without any in-hospital complications.

Manufacturer Narrative

Journal article: successful shockwave intravascular lithotripsy of an under-expanded stent after a month from primary implantation authors: szymon wlodarczak, piotr rola, mateusz barycki, marek szudrowicz, adrian wlodarczak, adrian doroszko, maciej lesiak journal: clinical vignette year: 2022 reference: doi: 10.33963/kp.A2022.0008.Date of publication.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: annex d codes added procedural images/data in the article provided the basis of the analysis.The images confirm the presence of a severely stenotic lesion in the lcx.Under-expansion of a stent can be observed.Further images depict a fully expanded stent at the lesion site.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: 15037290
• MDR Text Key: 296045395
• Report Number: 9612164-2022-02699
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P160043
• 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: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RONYX35030X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male