MAUDE Adverse Event Report: CORDIS CORPORATION LONG GEN / PRO 29 X 90 BIL 135; CATHETER, BILIARY, DIAGNOSTIC

Model Number PG2990BPX

Device Problems Loss of or Failure to Bond (1068); Premature Activation (1484); Device Dislodged or Dislocated (2923); Material Protrusion/Extrusion (2979)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2021

Event Type  malfunction  

Manufacturer Narrative

The product history review is expected but has not been completed.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the stent of a long genesis/pro 29 x 90 bil 135 stent delivery system (sds) fell off the balloon.When they were inspecting the stent before inserting into the body, the doctor saw it was not crimped securely on the balloon.The doctor tried to manually crimp the stent on the balloon by hand and also tried to roll the stent and balloon on the table technique to get the stent on the balloon, but was unsuccessful.The physician was not confident in using the device for the procedure and the procedure was completed with another, smaller palmaz genesis stent.There was no reported patient injury.The device never went in the body.Device packaging looked normal and did not have damage.The physician is trained and has used the device in the past.The target lesion was a renal artery.The physician noticed the stent was loose on the balloon and tried to "crimp/roll" the stent back, but was unsuccessful.The dilation catheter of the sds was successfully used later in the procedure to post dilate.The device will be returned for analysis.

Event Description

As reported, the stent of a long genesis/pro 29 x 90 bil 135 stent delivery system (sds) fell off the balloon.When they were inspecting the stent before inserting into the body, the doctor saw it was not crimped securely on the balloon.The doctor tried to manually crimp the stent on the balloon by hand and also tried to roll the stent and balloon on the table technique to get the stent on the balloon, but was unsuccessful.The physician was not confident in using the device for the procedure and the procedure was completed with another, smaller palmaz genesis stent.There was no reported patient injury.The device never went in the body.Device packaging looked normal and did not have damage.The physician is trained and has used the device in the past.The target lesion was a renal artery.The physician noticed the stent was loose on the balloon and tried to "crimp/roll" the stent back, but was unsuccessful.The dilation catheter of the sds was successfully used later in the procedure to post dilate.The device will be returned for analysis.Addendum: product analysis reveals the stent was observed partially expanded and some struts were observed bent.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82208528 presented no issues during the manufacturing process that can be related to the reported event.This device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available due to need for additional testing.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: the stent of a long genesis/pro 29 x 90 bil 135 stent delivery system (sds) fell off the balloon.When they were inspecting the stent before inserting into the body, the doctor saw it was not crimped securely on the balloon.The doctor tried to manually crimp the stent on the balloon by hand and also tried to roll the stent and balloon on the table technique to get the stent on the balloon, but was unsuccessful.The physician was not confident in using the device for the procedure and the procedure was completed with another, smaller palmaz genesis stent.There was no reported patient injury.The device never went in the body.Device packaging looked normal and did not have damage.The physician is trained and has used the device in the past.The target lesion was a renal artery.The physician noticed the stent was loose on the balloon and tried to "crimp/roll" the stent back, but was unsuccessful.The dilation catheter of the sds was successfully used later in the procedure to post dilate.The product was returned for analysis.One non-sterile long genesis / pro 29 x 90 biliary 135cm sds was received for analysis inside a plastic bag.No original packaging was returned.Per visual analysis, the balloon looks like it¿s been previously inflated since the balloon is observed fully expanded.Also, the stent was observed dislodged from the balloon.However, the stent was observed partially expanded and some struts were observed bent.No other anomalies were observed.Per microscopic analysis, stent marks were observed on the outer surface of the balloon catheter.A product history record (phr) review of lot 82208528 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent dislodged - during prep¿ and ¿stent strut uplift¿ were confirmed through analysis of the returned device.The reported ¿stent crimping difficulty¿ and ¿stent premature deployment¿ were not confirmed due to the presence of crimp marks on the inflated balloon.The exact cause of the events could not be determined during analysis.Based on the information available for review, handling and procedural factors may have contributed to the event as evidenced by previous inflation, dislodged stent despite crimp marks noted on the balloon and bent stent struts noted during analysis.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.¿ this is considered off label usage per 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 90 BIL 135
• Type of Device: 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: 12868030
• MDR Text Key: 283111113
• Report Number: 9616099-2021-05076
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 20705032039809
• UDI-Public: (01)20705032039809(17)231031(10)82208528
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: PG2990BPX
• Device Catalogue Number: PG2990BPX
• Device Lot Number: 82208528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 12/06/2021; 12/28/2021
• Supplement Dates FDA Received: 12/22/2021; 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PALMAZ GENESIS STENT
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 121 KG