MAUDE Adverse Event Report: CORDIS CORPORATION SHRT GEN / PRO 18 X 60 BIL 80; CATHETER, BILIARY, DIAGNOSTIC

Model Number	PG1860BPS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/01/1980
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis.No lot number was provided therefore a product history record (phr) review could not be generated.The reported ¿aneurysm¿ could not be confirmed as the device was not returned for analysis nor were images provided for review.The exact cause could not be determined.Vessel characteristics are unknown.The location of the implanted stent was not provided.Erroneous contact information was provided therefore it was not possible to contact the patient for additional information.Currently there is no medical evidence to suggest a causal relationship between the reported adverse event and stent implantation.As no lot number or other product information was supplied a phr could not be completed.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.¿ the very limited information available does not suggest a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
Event or Problem Description
The patient had a procedure with 80cm palmaz genesis transhepatic biliary stent on.035" 18 x 60 opta pro balloon expandable stent delivery system (sds) approximately 15 years ago and about a year after, got a brain aneurysm.The patient believed that the decomposing stent was the cause of her brain aneurysm.Her chief complaint was that she got the brain aneurysm due to the stent "breaking down" and she had reported this to her physician.She stated that her physician mentioned that there was not enough research on this for the brain aneurysm.The patient wanted to know the material composition of the stent, balloon, and guidewire for palmaz genesis on opta pro and the stent composition of the smart control.The device will not be returned for analysis.

• Brand Name: SHRT GEN / PRO 18 X 60 BIL 80
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 11877936
• Report Number: 9616099-2021-04577
• Device Sequence Number: 3559677
• Product Code: FGE
• UDI-Device Identifier: 20705032038321
• UDI-Public: 20705032038321
• Combination Product (Y/N): N
• PMA/510(K) Number: K012590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/25/2021

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 Model Number: PG1860BPS
• Device Catalogue Number: PG1860BPS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1