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

Device Problems Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 09/10/2020

Event Type  Injury  

Manufacturer Narrative

Journal article: partial stent extraction 14 months after stent implantation as a complication of cutting balloon authors: keisuke shoji, kan zen, kenji yanishi, satoaki matoba journal: cardiovascular intervention and therapeutics year: 2021 reference: doi.Org/10.1007/s12928-020-00704-z.If information is provided in the future, a supplemental report will be issued.

Event Description

An article titled - partial stent extraction 14 months after stent implantation as a complication of cutting balloon was submitted.A 2.50mm resolute onyx coronary drug-eluting stent (des) was implanted to treat an unprotected subtotal occlusion of the left circumflex artery.Approximately 11 months later a 99% in-stent restenosis (isr) was treated with a drug coated balloon.Approximately 14 months post stent implantation, a symptomatic focal isr recurred and intravascular ultrasound (ivus) demonstrated stent recoil due to severe calcification.A non-medtronic cutting balloon was used to prepare the lesion before implanting a new des.Resistance was felt when removing the cutting balloon after complete deflation.Approximately 7 mm of the proximal stent was inadvertently removed along with the cutting balloon.The patient remained hemodynamically stable, and optical coherence tomography confirmed recoil and avulsion of the neointima.The new des (2.75x12mm) was deployed at the extraction site.Final angiography and oct confirmed acceptable expansion of the stent.It was suspected that the cutting balloon flex point, which occurs every 5mm along the blade, became afixed to the proximal edge of the under expanded stent and caused the stent extraction.

Manufacturer Narrative

Additional information: annex d code added procedural images in the article confirm the reported in-stent restenosis and show the extracted stent 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12881103
• MDR Text Key: 281314412
• Report Number: 9612164-2021-04594
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/27/2022

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 11/29/2021
• Supplement Dates Manufacturer Received: 01/21/2022
• Supplement Dates FDA Received: 01/27/2022
• 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: 86 YR
• Patient Sex: Female