MAUDE Adverse Event Report: CORDIS US CORP. PALMAZ GENESIS ON OPTA PRO; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	PG5980BPS
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product history record review is anticipated; however, it has not yet been finalized.The device is available for analysis but has not been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, during prep, a palmaz genesis.035¿ 8x59 biliary stent was opened and fell off on the back table before inserting through the sheath to the treatment site.There was no reported patient injury.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
During prep, a palmaz genesis.035¿ 8x59 biliary stent delivery system (sds) was opened and fell off on the back table before inserting through the sheath to the treatment site.A new stent was opened and used to complete the procedure successfully.There was no reported patient injury.The intended procedure was reported as an iliac artery stenting.The product was stored and prepped properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use and no difficulty removing the product from the packaging.The stent was not crimped using a crimping tool, nor hand crimped.The balloon was not partially inflated to maintain the stent in place.There was no damage or deformation noted on the stent.The product was returned for analysis.A non-sterile unit of long palmaz genesis/opta pro 59 x 80 biliary 80cm sds was received coiled inside of a clear plastic bag.Per visual analysis the balloon was received not inflated, and it was observed that the stent was totally dislodged from the balloon as received.Per microscopic analysis stent struts marks were observed on the balloon surface.This indicates that the device complied with the stent crimp process.A product history record (phr) review of lot 82226833 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent dislodged¿ was confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.According to the conditions observed it was previously properly mounted on the balloon, as the stent struts marks were observed on the balloon surface indicating that the device complied with the stent crimp process.Based on the information available for review, procedural or handling factors may have contributed to the 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.¿ 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.
Event or Problem Description
As reported, during prep, a palmaz genesis.035¿ 8x59 biliary stent was opened and fell off on the back table before inserting through the sheath to the treatment site.A new stent was opened and used to completed the procedure successfully.There was no reported patient injury.The intended procedure was reported as an iliac artery stenting.The product was stored, and prepped properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use and no difficulty removing the product from the packaging.The stent was not crimped using a crimping tool, or hand crimp.The balloon was not partially inflated to maintain the stent in place.There was no damage or deformation noted on the stent.
Event or Problem Description
As reported, during prep, a palmaz genesis.035¿ 8x59 biliary stent was opened and fell off on the back table before inserting through the sheath to the treatment site.A new stent was opened and used to completed the procedure successfully.There was no reported patient injury.The intended procedure was reported as an iliac biopsy (bx) stenting.The product was stored, and prepped properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use and no difficulty removing the product from the packaging.The stent was not crimped using a crimping tool, or hand crimp.The balloon was not partially inflated to maintain the stent in place.There was no damage or deformation noted on the stent.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82226833 presented no issues during the manufacturing process that could be related to the event reported.The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: PALMAZ GENESIS ON OPTA PRO
• Common Device Name: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, florida 33014 ; 7863138372
• MDR Report Key: 16991769
• Report Number: 3007635982-2023-00186
• Device Sequence Number: 7039795
• Product Code: FGE
• UDI-Device Identifier: 20705032040393
• UDI-Public: (01)20705032040393(17)240531(10)82226833
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/01/2023

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: 05/31/2024
• Device Model Number: PG5980BPS
• Device Catalogue Number: PG5980BPS
• Device Lot Number: 82226833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2023
• Supplement Date Received by Manufacturer: 06/02/2023; 06/09/2023; 08/28/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 06/06/2023; 06/19/2023; 09/01/2023
• Date Device Manufactured: 06/28/2021
• 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: UNK SHEATH
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic