MAUDE Adverse Event Report: CORDIS CORPORATION STENT GENESIS XD 25MM; CATHETER, BILIARY, DIAGNOSTIC

Model Number	PG2510B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the patient had a stent fracture after a 25mm unmounted extra diameter (xd) palmaz genesis transhepatic biliary stent was placed.The biliary stent was broken in the pulmonary artery and a larger stent was added later.The device will be returned for evaluation.
Additional Manufacturer Narrative
The patient had a stent fracture after a 25mm unmounted extra diameter (xd) palmaz genesis transhepatic biliary stent was placed.The biliary stent was broken in the pulmonary artery and a larger stent was added later.The product was not returned for analysis.A product history record (phr) review of lot n0820300 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent fractured - in patient¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics, although unknown, may have contributed to the reported event.According to the indications for use in the safety information in the instructions for use ¿the palmaz genesis transhepatic biliary stent is indicated for palliation of malignant neoplasms in the biliary tree.The safety and effectiveness of this device for use in the vascular system have not been established.¿ this event is considered a violation of the ifu and as such, off label usage.Neither the phr nor the very limited information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: STENT GENESIS XD 25MM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12330674
• Report Number: 9616099-2021-04783
• Device Sequence Number: 14159664
• Product Code: FGE
• UDI-Device Identifier: 20705032057490
• UDI-Public: 20705032057490
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K020809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: PG2510B
• Device Catalogue Number: PG2510B
• Device Lot Number: N0820300
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 42