MAUDE Adverse Event Report: CORDIS CORPORATION UNKPALMAZCORONARY; STENT, CORONARY

Model Number UNKPALMAZCORONARY

Device Problems Therapy Delivered to Incorrect Body Area (1508); Device Dislodged or Dislocated (2923)

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

Event Date 11/22/1993

Event Type  Injury  

Manufacturer Narrative

As reported in the literature article, trerotola, s.O., lund, g.B., newman, j., olson, j.L., widlus, d.M., anderson, j.H., mitchell, s.E., & osterman, f.A., jr (1994).Repeat dilation of palmaz stents in pulmonary arteries: study of safety and effectiveness in a growing animal model.Journal of vascular and interventional radiology : jvir, 5(3), 425¿432.Https://doi.Org/10.1016/s1051-0443(94)71520-7, in one experimental animal (lamb), the stent was displaced from the balloon.The stent migrated to the left lower lobe pulmonary artery.Using catheter and guidewire manipulation, the stent was expanded in a satisfactory position.The stent got caught on or near the pulmonary valve and when the catheter was retracted to free the stent, the stent pulled off the balloon.The product was not returned for analysis.No lot number was provided therefore a product history record (phr) review could not be generated.The reported ¿stent dislodged - in patient¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics are unknown.As no lot number, catalogue code or other product information was supplied a phr could not be completed.According to the potential complications in the safety information in the instructions for use ¿potential complications associated with the peripheral artery stent implantation may include, but are not limited to, the following: stent migration/embolization¿.The very limited information available does not suggest a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

Event Description

As reported in the literature article, trerotola, s.O., lund, g.B., newman, j., olson, j.L., widlus, d.M., anderson, j.H., mitchell, s.E., & osterman, f.A., jr (1994).Repeat dilation of palmaz stents in pulmonary arteries: study of safety and effectiveness in a growing animal model.Journal of vascular and interventional radiology : jvir, 5(3), 425¿432.Https://doi.Org/10.1016/s1051-0443(94)71520-7, in one experimental animal (lamb), the stent was displaced from the balloon.The stent migrated to the left lower lobe pulmonary artery.Using catheter and guidewire manipulation, the stent was expanded in a satisfactory position.The stent got caught on or near the pulmonary valve and when the catheter was retracted to free the stent, the stent pulled off the balloon.The device will not be returned.

• Brand Name: UNKPALMAZCORONARY
• Type of Device: STENT, CORONARY
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; cordis corporation, FL 33014 ; 7863138372
• MDR Report Key: 11836537
• MDR Text Key: 261707547
• Report Number: 9616099-2021-04554
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKPALMAZCORONARY
• Device Catalogue Number: UNKPALMAZCORONARY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2021
• 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 Outcome(s): Other