MAUDE Adverse Event Report: CORDIS CORPORATION LONG GEN / PRO 29 X 10 BIL 135; CATHETER, BILIARY, DIAGNOSTIC

Model Number	PG2910BPX
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.This device is available for analysis but has not yet been received.
Event or Problem Description
As reported, the palmaz genesis pro 29 x 10 bil 135 stent was noted to have strut uplift on the distal end after removal from the plastic ring.This was noticed after the palmaz was handed off to the scrub tech to prep.The device was never used in the patient.The case was completed with an unknown device.There was no reported injury to the patient.The device was stored according to the instructions for use (ifu).There were no anomalies noted prior to removing the device.The distal end of the stent was noted to have stent strut uplift.The stent delivery system (sds) was prepped per the ifu.The stent was not manipulated during the prep.The stent was properly mounted on the system when inspected prior to use.The balloon was not inflated prior to insertion of the sds.The right iliac artery was the intended target lesion.The lesion was noted to be calcified with no tortuosity.The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.The device will be returned for evaluation.
Event or Problem Description
As reported, the palmaz genesis pro 29 x 10 bil 135 stent was noted to have strut uplift on the distal end after removal from the plastic ring.This was noticed after the palmaz was handed off to the scrub tech to prep.The device was never used in the patient.The case was completed with an unknown device.There was no reported injury to the patient.The device was stored according to the instructions for use (ifu).There were no anomalies noted prior to removing the device.The distal end of the stent was noted to have stent strut uplift.The stent delivery system (sds) was prepped per the ifu.The stent was not manipulated during the prep.The stent was properly mounted on the system when inspected prior to use.The balloon was not inflated prior to insertion of the sds.The right iliac artery was the intended target lesion.The lesion was noted to be calcified with no tortuosity.The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.The device will not be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b5, g3, h1, h2, h3 and h6.The palmaz genesis pro 29mm x 10mm biliary 135cm stent was noted to have strut uplift on the distal end after removal from the plastic ring.This was noticed after the palmaz was handed off to the scrub tech to prep.The device was never used in the patient.The case was completed with an unknown device.There was no reported injury to the patient.The device was stored according to the instructions for use (ifu).There were no anomalies noted prior to removing the device.The distal end of the stent was noted to have stent strut uplift.The stent delivery system (sds) was prepped per the ifu.The stent was not manipulated during the prep.The stent was properly mounted on the system when inspected prior to use.The balloon was not inflated prior to insertion of the sds.The right iliac artery was the intended target lesion.The lesion was noted to be calcified with no tortuosity.The product was not returned for analysis.A product history record (phr) review of lot 82173462 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent out of shape - strut uplift/during prep¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Procedural or handling factors 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.Prior to stenting, the palmaz genesis transhepatic biliary stent on opta pro.035¿ delivery system should be examined to verify functionality and integrity.¿ this intended device use is considered off label usage.Neither the phr review nor the information provided 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.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82173462 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the palmaz genesis pro 29 x 10 bil 135 stent was noted to have strut uplift on the distal end after removal from the plastic ring.This was noticed after the palmaz was handed off to the scrub tech to prep.The device was never used in the patient.The case was completed with an unknown device.There was no reported injury to the patient.The device was stored according to the instructions for use (ifu).There were no anomalies noted prior to removing the device.The distal end of the stent was noted to have stent strut uplift.The stent delivery system (sds) was prepped per the ifu.The stent was not manipulated during the prep.The stent was properly mounted on the system when inspected prior to use.The balloon was not inflated prior to insertion of the sds.The right iliac artery was the intended target lesion.The lesion was noted to be calcified with no tortuosity.The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.The device will be returned for evaluation.

• Brand Name: LONG GEN / PRO 29 X 10 BIL 135
• 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: 14135057
• Report Number: 9616099-2022-05551
• Device Sequence Number: 6291025
• Product Code: FGE
• UDI-Device Identifier: 20705032039441
• UDI-Public: (01)20705032039441(17)220630(10)82173462
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup,Followup
• Report Date (Section B): 07/28/2022

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: 06/30/2022
• Device Model Number: PG2910BPX
• Device Catalogue Number: PG2910BPX
• Device Lot Number: 82173462
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 04/19/2022; 07/22/2022
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 05/13/2022; 07/28/2022
• Date Device Manufactured: 07/04/2019
• 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
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 75 KG