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

Model Number RSINT35018X

Device Problems Fracture (1260); Improper or Incorrect Procedure or Method (2017); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problems Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 01/15/2024

Event Type  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.

Event Description

An attempt was made to use one 3.5x18mm resolute integrity coronary drug eluting stent to treat a non-tortuous, non-calcified lesion with greater than 60% stenosis in the ostium left main (lm) coronary artery.The device was inspected with no issues.Negative prep was not performed.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during the delivery. it was reported that the stent was post-dilated using a 5.0mm non-compliant (nc) balloon.This resulted in the stent deforming in the lm, and loss of radial resistance.Thrombus formation occurred.A 4x18mm resolute integrity stent was deployed to cover the deformed 3.5x18mm resolute integrity stent.It was noted that there was an unawareness of the product's manufacturer serial identification (msid), leading to use of the 5mm nc balloon.Multiple other medtronic devices were used during the procedure.The patient is alive with no further injury.

Manufacturer Narrative

Additional information: the patient had a severely diseased left coronary system.The 5.0mm non-compliant (nc) balloon used for stent post-dilation was a non-medtronic device.The stented vessel recoiled to an unacceptable result, and malapposition may have occurred as the stent strut was in disarray under angiography.However, no intravascular was performed and this remains inconclusive.Thrombus formation occurred at proximal left anterior descending (lad) artery.The thrombus formation occurred after the percutaneous coronary intervention (pci) was performed on the lm.A medtronic advance ce aspiration catheter was used to treat the thrombus.There is no complaint against the advance ce device.It was believed that the thrombus was related to a fractured strut following off label over-expansion.However, no act test was obtained during the pci, and therefore it is not possible to rule out hyper-coagulability due to reduced heparinization.It was noted that there was an unawareness of the product's maximum stent internal diameter (msid), leading to use of the 5mm nc balloon.Multiple other medtronic devices were used during the procedure with no issues noted.There was no complaint against 4.00x18x resolute integrity stent.It was assessed that the thrombus event was directly related to the use of the relevant device.The patient was admitted in the intensive care unit (icu) as per hospital high risk pci protocol.Still image analysis: one image received from the account for review.The image shows the device label of multiple devices.One is of a resolute integrity confirming the lot and size of the device.Lot number 0011348406 and size 3.5mm x 18mm.Unable to confirm the reported event from the image provided.Cine image analysis: nine still fluoroscopic procedural images of the left coronary system were provided for review.A lesion in the left main and in the proximal lad were identified.Images confirmed the delivery and post deployment profile of the initial stent, but no deformation could be confirmed.The alleged thrombus could not be confirmed from the images.The delivery but not deployment of the second stent is confirmed.The images provided confirm that the left coronary system was treated but the alleged stent deformation or thrombus are inconclusive from the images 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.

Manufacturer Narrative

Additional information: annex d codes added.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: STENT, CORONARY, DRUG-ELUTING
• 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: 18585997
• MDR Text Key: 333774627
• Report Number: 9612164-2024-00440
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RSINT35018X
• Device Catalogue Number: RSINT35018X
• Device Lot Number: 0011348406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Date Device Manufactured: 08/06/2022
• 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): Other; Required Intervention; Hospitalization
• Patient Age: 47 YR
• Patient Sex: Male