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

Catalog Number	PG2910BPX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82228150 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the 29x10 palmaz genesis opta pro was attempted to be inserted through a non-cordis 7f sheath.Upon insertion the stent slipped from the delivery system (outside the body).The stent was unable to be used.A second 19x10 palmaz genesis opta pro was inserted into the sheath.The stent moved slightly but was able to be delivered.The metal insertion tube was not used on the first stent but was used on the second.There was no reported injury to the patient.Ultrasound guidance was used during access.The target vessel was the left common carotid artery.The device was stored and opened per the instructions for use (ifu).There were no anomalies noted to either device prior to use.They were prepped per the ifu without difficulty.The stent was not manipulated during prep on either device.The stents were properly mounted on the system when inspected prior to use.The balloons were not inflated or partially inflated prior to inserting into the patient.Negative pressure was not applied to either system.Unusual force was not used at any time during the procedure.There was no difficulty crossing the lesion with the 20x10 (second stent).The 10x29 palmaz will be returned for evaluation.
Additional Manufacturer Narrative
The 29x10 palmaz genesis opta pro was attempted to be inserted through a non-cordis 7f sheath.Upon insertion the stent slipped from the delivery system (outside the body).The stent was unable to be used.A second 19x10 palmaz genesis opta pro was inserted into the sheath.The stent moved slightly but was able to be delivered.The metal insertion tube was not used on the first stent but was used on the second.There was no reported injury to the patient.Ultrasound guidance was used during access.The target vessel was the left common carotid artery.The device was stored and opened per the instructions for use (ifu).There were no anomalies noted to either device prior to use.They were prepped per the ifu without difficulty.The stent was not manipulated during prep on either device.The stents were properly mounted on the system when inspected prior to use.The balloons were not inflated or partially inflated prior to inserting into the patient.Negative pressure was not applied to either system.Unusual force was not used at any time during the procedure.There was no difficulty crossing the lesion with the 20x10 (second stent).The product was returned for analysis.A non-sterile unit of long palmaz genesis / pro 29 x 10 biliary stent delivery system (sds) 135cm was received coiled inside of a clear plastic bag.Per visual analysis the balloon was received not inflated without the stent mounted.In addition, the balloon protector was returned.The stent was not returned for analysis.No damages or anomalies were observed on the returned unit.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 82228150 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.Based on the information available for review, procedural or handling factors may have contributed to the event as evidenced by stent crimp marks noted on the outer surface during analysis.The reported ¿stent loose crimp¿ was not confirmed as the device was not returned for analysis.According to the precautions in the safety information in the instructions for use ¿prior to stenting, the palmaz genesis peripheral stent on opta pro.035" delivery system should be examined to verify functionality and integrity.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.¿ this is considered off label usage when used in the vascular system.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, the 29x10 palmaz genesis opta pro was attempted to be inserted through a non-cordis 7f sheath.Upon insertion the stent slipped from the delivery system (outside the body).The stent was unable to be used.A second 19x10 palmaz genesis opta pro was inserted into the sheath.The stent moved slightly but was able to be delivered.The metal insertion tube was not used on the first stent but was used on the second.There was no reported injury to the patient.Ultrasound guidance was used during access.The target vessel was the left common carotid artery.The device was stored and opened per the instructions for use (ifu).There were no anomalies noted to either device prior to use.They were prepped per the ifu without difficulty.The stent was not manipulated during prep on either device.The stents were properly mounted on the system when inspected prior to use.The balloons were not inflated or partially inflated prior to inserting into the patient.Negative pressure was not applied to either system.Unusual force was not used at any time during the procedure.There was no difficulty crossing the lesion with the 20x10 (second stent).The 10x29 palmaz will be returned for evaluation.

• 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 FL 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 ; 7863138372
• MDR Report Key: 17587436
• Report Number: 3007635982-2023-00267
• Device Sequence Number: 6392413
• Product Code: FGE
• UDI-Device Identifier: 20705032039441
• UDI-Public: (01)20705032039441(17)240630(10)82228150
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023

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?: No
• Device Expiration Date: 06/30/2024
• Device Catalogue Number: PG2910BPX
• Device Lot Number: 82228150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2021
• 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: 7FR X70 COOK RAABE SHEATH
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 84 KG