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

Model Number RSINT35022X

Device Problems Fracture (1260); Material Deformation (2976)

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

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

An attempt was made to use one resolute integrity coronary drug eluting stent to treat a lesion.It was reported that the end of the stent was kinked during use and broke after kinking in the opposite direction.The stent was replaced with a new stent.The patient is alive with no injury.

Manufacturer Narrative

Additional information: the device was inspected before use with no issues.It was later reported that the kink did not occur during use inside the patient.The kink/bend was found out during device preparation.The device kink was attempted to be straightened.The stent was not broken, but the push rod was broken.The stent was replaced with a new non-medtronic stent.The device did not enter the patient's vasculature, and was not used in the patient.Image analysis: three still images were provided for analysis.First image depicts a resolute integrity shelf carton label.Labelling information matches that reported in the complaint file.Second image depicts a resolute integrity device partially loaded in the hoop.A detachment is evident to the proximal section of the hypo-tube, with a kink visible distal to the luer and other kinks evident to the hypo-tube inside the hoop, distal to the detachment site.Third image depicts a resolute integrity hoop with the hypo-tube loaded.A kink is evident to the hypo-tube inside the hoop.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 19142201
• MDR Text Key: 341007159
• Report Number: 9612164-2024-01895
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RSINT35022X
• Device Catalogue Number: RSINT35022X
• Device Lot Number: 0011736766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• Date Device Manufactured: 04/18/2023
• 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 Age: 64 YR
• Patient Sex: Male