MAUDE Adverse Event Report: CORDIS CORPORATION STENT PER 15MM MEDIUM; CATHETER, BILIARY, DIAGNOSTIC

Model Number	P154
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/1999
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was found during a recent clinical evaluation review/literature search of this device.The citation is as follows: slonim, s.M., dake, m.D., razavi, m.K., kee, s.T., samuels, s.L., rhee, j.S., & semba, c.P.(1999).Management of misplaced or migrated endovascular stents.Journal of vascular and interventional radiology : jvir, 10(7), 851¿859.Https://doi.Org/10.1016/s1051-0443(99)70127-2.Specific product details are not available.The exact event date is unknown.Complaint conclusion: according to the literature article by slonim, s.M., dake, m.D., razavi, m.K., kee, s.T., samuels, s.L., rhee, j.S., & semba, c.P.(1999).Management of misplaced or migrated endovascular stents.Journal of vascular and interventional radiology : jvir, 10(7), 851¿859.Https://doi.Org/10.1016/s1051-0443(99)70127-2, a palmaz p154 stent was intended to be placed in the axillary vein but migrated to the right ventricle due to it being too small.Percutaneous retrieval was unsuccessful due to the patient developing chest pain when traction was placed on a snare passed around the stent.The stent had to be surgically removed from the heart and at surgery, the stent was found to be entangled in the tricuspid valve.The patient developed tricuspid regurgitation after attempted stent retrieval, which may have been caused by manipulation of the stent.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 migration¿, ¿chest pain¿ and ¿tricuspid regurgitation¿ 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 was supplied a phr could not be completed.According to the safety information in the instructions for use ¿the palmaz balloon-expandable peripheral stent is indicated for use in the treatment of atherosclerotic disease in peripheral arteries below the aortic arch and for palliation of malignant neoplasms in the biliary tree.Measure the diameter of the reference vessel to determine the appropriate size stent and delivery system.¿ as the product is indicated for use in the arteries and this product was used in the vein it is considered off label usage and a violation of the ifu.The 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 or Problem Description
According to the literature article by slonim, s.M., dake, m.D., razavi, m.K., kee, s.T., samuels, s.L., rhee, j.S., & semba, c.P.(1999).Management of misplaced or migrated endovascular stents.Journal of vascular and interventional radiology : jvir, 10(7), 851¿859.Https://doi.Org/10.1016/s1051-0443(99)70127-2, a palmaz p154 stent was intended to be placed in the axillary vein but migrated to the right ventricle due to it being too small.Percutaneous retrieval was unsuccessful due to the patient developing chest pain when traction was placed on a snare passed around the stent.The stent had to be surgically removed from the heart and at surgery, the stent was found to be entangled in the tricuspid valve.The patient developed tricuspid regurgitation after attempted stent retrieval, which may have been caused by manipulation of the stent.The device will not be returned for evaluation.

• Brand Name: STENT PER 15MM MEDIUM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11928390
• Report Number: 9616099-2021-04595
• Device Sequence Number: 3181786
• Product Code: FGE
• UDI-Device Identifier: 20705032057247
• UDI-Public: 20705032057247
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/03/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: P154
• Device Catalogue Number: P154
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN 3-5MM BALLOON CATHETER
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention