MAUDE Adverse Event Report: CORDIS CORPORATION LONG GEN / PRO 29 X 10 BIL 80; CATHETER, BILIARY, DIAGNOSTIC

Model Number	PG2910BPS
Medical Device Problem Codes	Structural Problem (2506); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a palmaz genesis long pro bil 29mm x 10mm x 80cm stent delivery system (sds) would not cross a calcified common iliac lesion.The procedure was completed with another unknown stent.There was no reported patient injury.There was no difficulty experienced in prepping the device.An ipsilateral approach was used.The common iliac ha moderate calcification, mild tortuosity, 70% stenosis, acute angulation, no bifurcation, and not a cto.The device did not kink or bend at any time prior to the reported complaint.The device was stored and prepped as per the instructions for use (ifu).The user was trained with the device.The device will be returned for evaluation.During visual inspection of the returned device, the stent was observed slightly moved from its original position and partially opened from the initial section of the component.
Additional Manufacturer Narrative
As reported, a palmaz genesis long pro bil 29mm x 10mm x 80cm stent delivery system (sds) would not cross a calcified common iliac lesion.The procedure was completed with another unknown stent.There was no reported patient injury.There was no difficulty experienced in prepping the device.An ipsilateral approach was used.The common iliac had moderate calcification, mild tortuosity, 70% stenosis, acute angulation, no bifurcation, and not a cto.The device did not kink or bend at any time prior to the reported complaint.The device was stored and prepped as per the instructions for use (ifu).The user was trained with the device.During visual inspection of the returned device, the stent was observed slightly moved from its original position and partially opened from the initial section of the component.The product was returned for analysis.One non-sterile long genesis / pro 29 x 10 biliary 80cm sds was received coiled for analysis inside a plastic bag.Per visual analysis, the stent was observed slightly moved from its original position and partially opened from the initial section of the component).No other anomalies were observed.Per microscopic analysis marks on the balloon are noted where the stent was originally placed.Additionally, a partially opened stent could be observed.A product history record (phr) review of lot 82214956 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent - offset/out of position" and "stent - out of shape - strut uplift¿ were confirmed through analysis of the returned device.The reported ¿stent delivery system (sds) - failure to cross¿ was not confirmed through analysis of the returned device due to the nature of the complaint.Procedural images were not provided for review.The exact cause of the event could not be determined during analysis.Based on the information available for review, vessel characteristics (moderate calcification, mild tortuosity, 70% stenosis, acute angulation) may have contributed to the event as evidenced by the stent strut uplift noted during analysis.Procedural and/or handling factors may have also contributed to the observed conditions on the sds/stent.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.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 is considered off label usage per the ifu.Neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: LONG GEN / PRO 29 X 10 BIL 80
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• 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; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13225291
• Report Number: 9616099-2022-05282
• Device Sequence Number: 3957854
• Product Code: FGE
• UDI-Device Identifier: 20705032039434
• UDI-Public: (01)20705032039434(17)240131(10)82214956
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: PG2910BPS
• Device Catalogue Number: PG2910BPS
• Device Lot Number: 82214956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN STENT
• Patient Age: 77 YR
• Patient Sex: Male