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

Catalog Number	PG3910BPS
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: when removing a 39mm x 10mm palmaz genesis on opta pro stent delivery system (sds), the stent fell off the balloon.The stent was not manipulated and fell off the device prior to preparation.The device never went into the patient and a non-cordis stent was used to treat the intended lesion.There were no patient injuries reported.The palmaz genesis stent was to be implanted in the iliac artery during an endovascular aneurysm repair (evar) procedure.The packaging was opened correctly, and the stent did not appear prematurely expanded.The product was not returned for analysis.A product history record (phr) review of lot 82226829 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent dislodged¿ 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 (ifu), ¿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.¿ this is considered off label usage and a violation of the ifu.Neither the phr review nor the limited 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.H3 other text : device discarded.
Event or Problem Description
As reported, when removing a 39mm x 10mm palmaz genesis on opta pro stent delivery system (sds), the stent fell off of the balloon.The stent was not manipulated and fell off of the device prior to preparation.The device never went into the patient and a non-cordis stent was used to treat the intended lesion.There were no patient injuries reported.The palmaz genesis stent was to be implanted in the iliac artery during an endovascular aneurysm repair (evar) procedure.The packaging was opened correctly, and the stent did not appear prematurely expanded.The device was discarded and will not be returned.

• 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 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 CR 2 -01 0 ; CS CR 2 01 02 ; 7863138372
• MDR Report Key: 18284450
• Report Number: 3007635982-2023-00341
• Device Sequence Number: 6696027
• Product Code: FGE
• UDI-Device Identifier: 20705032039830
• UDI-Public: (01)20705032039830(17)240531(10)82226829
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/07/2023

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
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: PG3910BPS
• Device Lot Number: 82226829
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: BOSTON STENT.
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White