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

Model Number RSINT25026X

Device Problems Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problems Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

Event Date 03/19/2024

Event Type  Injury  

Event Description

An attempt was made to use one resolute integrity drug eluting stent to treat a lesion in the distal right coronary artery (rca).The lesion was pre-dilated.It was reported that the stent could not be delivered to the distal target lesion.When the stent system was withdrawn, stent dislodgement occurred.An attempt to capture the stent failed.The dislodged stent flowed with the blood to the distal segment of the left popliteal artery.The right femoral artery was punctured.  a 6f jr4 guide catheter was inserted into the proximal segment of the left popliteal artery.A 4.0 x 33mm non-medtronic drug eluting stent and a 4.0 x 22mm medtronic drug eluting stent were positioned and deployed at the proximal and distal sections of the dislodged stent in the left popliteal artery which completely covered the dislodged stent.The patient had no discomfort after the surgery.No further patient injury was reported.

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.

• 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: 19190316
• MDR Text Key: 341119532
• Report Number: 9612164-2024-02001
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2024

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
• Device Model Number: RSINT25026X
• Device Catalogue Number: RSINT25026X
• Device Lot Number: 0012009236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/26/2024
• Date Device Manufactured: 10/25/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male