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

Model Number RSINT27522X

Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2022

Event Type  malfunction  

Event Description

An attempt was made to use two resolute integrity rx coronary drug eluting stent to treat a severely tortuous, severely calcified lesion with 95% stenosis, in the mid circumflex (cx) artery. the devices were inspected with no issues noted.Negative prep was performed on both device with no issues noted.The lesion was pre-dilated.The devices did not pass through a previously deployed stent.Resistance was encountered when advancing the devices.Excessive force was used during delivery for the first stent (rsint27522x).It was reported that stent deformation occurred in vivo during positioning/advancement for both devices. the procedure was completed with a 2.5 x 18mm resolute integrity stent and a 2.75 x 12mm resolute integrity stent.It was detailed that a non-medtronic (mdt) guidewire was passed through the lesion.Percutaneous transluminal coronary angioplasty (ptca) was made with a 2.5 x 15mm non-mdt balloon to the lesion area.Full clarity was maintained.70%, 95% and 70% strictures in the cx artery were passed with the non-mdt guidewire.Ptca was made with a 2.5 x 15mm and a 2.75 x 15mm non-mdt balloons to 95% lesion area.This caused suboptimal result and a 2.75 x 18mm non-mdt drug eluting stent (des) was implanted.Due to 40% residual a percutaneous transluminal angioplasty (pta), was made with a 3.0 x 15mm non-mdt nc balloon into the stent.Full weakness was maintained.Due to reference to distal 70% lesion a 2.5 x 18mm resolute integrity des implanted due to the reference carrier api 2.5mm and lesion length 18mm.Reference to proximal 70% lesion vessel diameter 2.75.A 2.75 x 12mm resolute integrity des was implanted due to the length of mm and lesion is 12mm.Full clarity given.Opaxol 350mg (contrast agent) 200ml bottle was used during the procedure.It was stated that the event was due to use of the device in difficult lesion morphology/anatomy, i.E.The event was procedural related and not device related. the patient is alive with no injury.

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.

Manufacturer Narrative

Correction: the devices were not implanted in the patient.Facility address.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: stent deformation in vivo occurred on both devices due to a tight vessel lesion a 2.75 x 18mm resolute integrity des device was implanted in the distal lesion, a 2.5 x 30 mm resolute integrity des device was implanted in the cx, and a 2.75 x 12mm resolute integrity des device was implanted in the proximal lesion.A 2.5 x 18mm resolute integrity des device was also used during the procedure.No issues were note with the other resolute integrity devices used to completed the procedure.Product analysis: the device was received for analysis.The stent was not present on the balloon but had dislodged proximally along the distal shaft.The balloon folds remained intact.The stent crimp impressions were visible on the exposed balloon surface.The stent was fully stretched and deformed along the distal shaft and did not meet visual acceptance specification.Deformation was evident to the proximal, mid and distal stent wraps with struts stretched.Deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.No other damage evident to the remainder of the device.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: a non-medtronic balloon was used for pre-dilatation.Annex d codes.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 INTEGRITY 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: 16014480
• MDR Text Key: 308451118
• Report Number: 9612164-2022-04836
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2024
• Device Model Number: RSINT27522X
• Device Catalogue Number: RSINT27522X
• Device Lot Number: 0010597631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2021
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 82 KG