MAUDE Adverse Event Report: CORDIS CORPORATION STENT PER 30MM 4.0MM LARGE; CATHETER, BILIARY, DIAGNOSTIC

Model Number	P308
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 article was found during a recent clinical evaluation review/literature search of this device.The report also represents notification of 1 event for stent migration.Please note that patient specific details (demographics, medical history and reason for intervention) are not available.The devices are palmaz stents, but the catalog and lot numbers are not available.The citation is as follows " 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".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 p308 stent was intended to be placed in the hepatic inferior vena cava (ivc) but migrated to the renal ivc due to rupture of the unknown balloon.The stent was repositioned in the ivc percutaneously with another unknown 3-5mm balloon catheter.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 migration¿ 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 a 316l stainless steel, slotted tube.The stent should be crimped over the recommended balloon delivery catheter.See materials required table for the recommended cordis maxi¿ ds, and powerflex® plus individual product descriptions, and recommended accessory devices.¿ the recommended balloon was the maxi ds.It is not known if the recommended balloon was used in this case.The 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 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 p308 stent was intended to be placed in the hepatic inferior vena cava (ivc) but migrated to the renal ivc due to rupture of the unknown balloon.The stent was repositioned in the ivc percutaneously with another unknown 3-5mm balloon catheter.The device will not be returned for evaluation.

• Brand Name: STENT PER 30MM 4.0MM LARGE
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 11959687
• Report Number: 9616099-2021-04618
• Device Sequence Number: 11093291
• Product Code: FGE
• UDI-Device Identifier: 20705032057292
• UDI-Public: 20705032057292
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K911581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: P308
• Device Catalogue Number: P308
• 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: 06/08/2021
• 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: ANOTHER UNKNOWN 3-5MM BALLOON CATHETER; UNKNOWN BALLOON
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention