MAUDE Adverse Event Report: CORDIS CORPORATION LONG GEN / PRO 59 X 80 BIL 80; CATHETER, BILIARY, DIAGNOSTIC

Model Number	PG5980BPS
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product remains implanted and is thus not available for analysis.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the 8mm x 59mm x 80cm palmaz genesis transhepatic biliary stent on.035¿ opta pro percutaneous transluminal angioplasty (pta) delivery system dislodged from the balloon inside the patient.The patient was fine, but they had to use another unknown stent.The left iliac artery was pre dilated with a powerflex 5 x 40 at 10 atmospheres (atm).They crossed the area with a 9 x 39 genesis with no issues prior to placing the 8 x 59.The patient had a medical history of peripheral vascular disease.The intended procedure/target lesion was the iliac artery.Vessel / lesion characteristics, the lesion had little calcification.The vessel had little tortuosity.The vessel had no angulation.The device was not used for a chronic total occlusion (total occlusion >3 months).The device was not resterilized.There were no anomalies noted when removed from the package.There were no anomalies noted during prep.The device was not inserted through a stopcock instead of a hemostatic valve.The segment was left i the iliac artery.The patient is stable after the event.The device will not be returned as it remained in the patient.
Additional Manufacturer Narrative
The 8mm x 59mm x 80cm palmaz genesis transhepatic biliary stent on.035¿ opta pro percutaneous transluminal angioplasty (pta) delivery system dislodged from the balloon inside the patient.The patient was fine, but they had to use another unknown stent.The left iliac artery was pre dilated with a powerflex 5 x 40 at 10 atmospheres (atm).They crossed the area with a 9 x 39 genesis with no issues prior to placing the 8 x 59.The patient had a medical history of peripheral vascular disease.The intended procedure/target lesion was the iliac artery.Vessel / lesion characteristics, the lesion had little calcification.The vessel had little tortuosity.The vessel had no angulation.The device was not used for a chronic total occlusion (total occlusion >3 months).The device was not resterilized.There were no anomalies noted when removed from the package.There were no anomalies noted during prep.The device was not inserted through a stopcock instead of a hemostatic valve.The segment was left iliac artery.The patient is stable after the event.The product was not returned for analysis.A product history record (phr) review of lot 82184380 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent dislodged - in patient¿ could not be confirmed as the device was not returned for analysis, nor was procedural imagery provided for review.The exact cause could not be determined.Vessel characteristics, although not clear, may have contributed to the reported event.According to the safety information in the instructions for use ¿the cordis palmaz genesis transhepatic biliary stent on opta pro.035¿ delivery system is indicated for palliation of malignant neoplasms in the biliary tree.The safety and effectiveness of the palmaz genesis transhepatic biliary stent on opta pro.035¿ delivery system for use in the vascular system have not been established.Prior to stenting, the palmaz genesis transhepatic biliary stent on opta pro.035¿ delivery system should be examined to verify functionality and integrity.Inspect the crimped stent for adherence to the balloon and centered placement in relation to the balloon marker bands.Do not reposition the stent or hand crimp.Caution: if strong resistance is met during advancement or withdrawal of the catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.B.Under fluoroscopy, use the balloon marker bands and the radiopaque stent to position the stent centrally within the stricture.During positioning, verify that the stent is still centered within the balloon marker bands and has not been dislodged.¿ this device is not indicated for the vasculature and as such is considered off label usage.Neither the phr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: LONG GEN / PRO 59 X 80 BIL 80
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11544683
• Report Number: 9616099-2021-04355
• Device Sequence Number: 2965768
• Product Code: FGE
• UDI-Device Identifier: 20705032040393
• UDI-Public: 20705032040393
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K012590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2021

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 Expiration Date: 12/31/2022
• Device Model Number: PG5980BPS
• Device Catalogue Number: PG5980BPS
• Device Lot Number: 82184380
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 04/22/2021
• 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: 39 GENESIS; POWERFLEX 5X40