MAUDE Adverse Event Report: MEDTRONIC VASCULAR INTEGRITY CORONARY STENT SYSTEM 2.5 MM X 26 MM ; STENT, CORONARY

Model Number INT25026UX

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/24/2020

Event Type  Injury  

Event Description

Patient with a history of coronary artery disease status post stenting.He arrived to the hospital as an outpatient to undergo coronary angiography and possible stent placement.During the procedure, one of the stents embolized and was found to be lodged in the right tibioperoneal trunk, for which vascular surgery was consulted.Patient currently denies any complaints of pain or discomfort associated with his right leg.Denies any sensory or motor deficits.States his only pain is from his groin incisions associated with his coronary angiography.Denies any other complaints including headaches, chest pain, shortness of breath, abdominal pain, nausea or vomiting, pelvic pain, urinary itching or burning, or numbness or tingling in any of his extremities.Interventions: percutaneous coronary intervention of the left circumflex artery was performed.We cannulated the left main with xb 3.56 french guide.The mid circumflex lesion was crossed with pro-water wire 0.014.We initially tried to stent the lesion with a bare-metal stent integrity 2.5x 26.However, were unable to pass the lesion, therefore we retrieved the stent.However during the process of removing the stent, it was dislodged.The guide and pro-water wire were removed from the sheath.Upon performing fluoroscopy exam, the stent was noticed in the common femoral artery area close to the tip of the femoral sheath.The stent got embolized downstream the femoral artery system.Vascular surgery was consulted.Patient currently denies any complaints of pain or discomfort associated with his right leg.Denies any sensory or motor deficits.Plan: stent is lodged in the distal tibioperoneal trunk mostly in peroneal artery with flow through the stent with evidence of flow through all outflow vessels.Dopplerable signals unchanged and intact.Patient is asymptomatic and denies any sensory or motor deficits.No evidence of limb ischemia.At this point, attempts to retrieve the stent would potentially cause more harm with possible vascular injury including tears and dissection leading to worse and clinically significant issues.Patient will need long-term surveillance of his right lower extremity vessels.

• Brand Name: INTEGRITY CORONARY STENT SYSTEM 2.5 MM X 26 MM
• Type of Device: STENT, CORONARY
• Manufacturer (Section D): MEDTRONIC VASCULAR
• MDR Report Key: 10024505
• MDR Text Key: 190004802
• Report Number: MW5094373
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/26/2020
• Device Model Number: INT25026UX
• Device Lot Number: 0009207046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 57 YR
• Patient Weight: 65