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

Catalog Number PG3970BPS

Device Problems Leak/Splash (1354); Therapy Delivered to Incorrect Body Area (1508)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2023

Event Type  Injury  

Event Description

As reported, the 39 x 70 palmaz genesis pro stent deployed partial, and the balloon malfunctioned before inflation.The stent was not within the intended lesion.A second stent was needed to cover the lesion.There was no reported injury to the patient.The damage was noted after the device was inserted into the vessel.The device was stored per the instructions for use (ifu).There were no anomalies noted prior to use.The sds was prepped according to ifu guidelines without difficulty.The stent was not manipulated during prep.The stent was properly mounted on the system when inspected prior to use.Prior to inserting the sds in the catheter, the balloon was not inflated or partially inflated.The lesion was noted to be calcified.The device was not being used to treat a chronic total occlusion (cto).The device will be returned for evaluation.

Manufacturer Narrative

This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b5, d4, g3, h1, h2, h3 and h6 a review of the manufacturing documentation associated with lot 82220929 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 Description

As reported, the 39 x 70 palmaz genesis pro stent deployed partial, and the balloon malfunctioned before inflation.The stent was not within the intended lesion.A second stent was needed to cover the lesion.There was no reported injury to the patient.The damage was noted after the device was inserted into the vessel.The device was stored per the instructions for use (ifu).There were no anomalies noted prior to use.The sds was prepped according to ifu guidelines without difficulty.The stent was not manipulated during prep.The stent was properly mounted on the system when inspected prior to use.Prior to inserting the sds in the catheter, the balloon was not inflated or partially inflated.The lesion was noted to be calcified.The device was not being used to treat a chronic total occlusion (cto).The device will be returned for evaluation.

Manufacturer Narrative

The 39 x 70mm palmaz genesis pro stent partially deployed, and the balloon malfunctioned before inflation.The stent was not within the intended lesion.A second stent was needed to cover the lesion.The lesion was noted to be calcified.There was no reported injury to the patient.The damage was noted after the device was inserted into the vessel.The device was stored per the instructions for use (ifu).There were no anomalies noted prior to use.The sds was prepped according to ifu guidelines without difficulty.The stent was not manipulated during prep.The stent was properly mounted on the system when inspected prior to use.Prior to inserting the sds in the catheter, the balloon was not inflated or partially inflated.The device was not being used to treat a chronic total occlusion (cto).The product was returned for analysis.A non-sterile unit of palmaz long genesis / pro 39 x70mm biliary 80cm stent delivery system was received for analysis coiled inside of a clear plastic bag.Per visual analysis the unit does not present any kinked condition.The balloon is not inflated, and the stent was not returned for analysis.No other anomalies were noted.Per functional analysis a balloon inflation test was done applying positive pressure using the inflator/deflator device with the purpose of reaching the rated burst pressure.However, inflating the balloon was not possible due to an observed leak condition.Per sem analysis the balloon surface presented evidence of a puncture and secondary scratch marks near the first scratch observed.This type of damage.Is commonly caused during the interaction of the material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the surface could probably led to the damaged condition found on the received device.It seems that the material near the damaged area was affected with a sharp object from the outside of the device.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82220929 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon leakage¿ was confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.The reported ¿stent inaccurate placement¿ was not confirmed through analysis of the returned device as procedural images were not provided for review.The exact cause of the event could not be determined during analysis.Based on the information available for review, vessel characteristics (calcification) may have contributed to the event as evidenced by abrasions noted on the outer surface during analysis as the presence of calcification is known to cause damage to balloons.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.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.Caution: if strong resistance is met during advancement or withdrawal of the catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.B.Under fluoroscopy, use the balloon marker bands and the radiopaque stent to position the stent centrally within the stricture.During positioning, verify that the stent is still centered within the balloon marker bands and has not been dislodged.¿ additionally, the intended use of this device in the vascular system is considered off label usage.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 Description

As reported, the 39 x 70 palmaz genesis pro stent partially deployed, and the balloon malfunctioned before inflation.The stent was not within the intended lesion.A second stent was needed to cover the lesion.There was no reported injury to the patient.The damage was noted after the device was inserted into the vessel.The device was stored per the instructions for use (ifu).There were no anomalies noted prior to use.The sds was prepped according to ifu guidelines without difficulty.The stent was not manipulated during prep.The stent was properly mounted on the system when inspected prior to use.Prior to inserting the sds in the catheter, the balloon was not inflated or partially inflated.The lesion was noted to be calcified.The device was not being used to treat a chronic total occlusion (cto).The device will be returned for evaluation.

• Brand Name: PALMAZ GENESIS ON OPTA PRO
• Type of Device: 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: 17539916
• MDR Text Key: 321053150
• Report Number: 3007635982-2023-00258
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 20705032040034
• UDI-Public: (01)20705032040034(17)240331(10)82220929
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2023

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
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: PG3970BPS
• Device Lot Number: 82220929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 08/10/2023; 11/14/2023
• Supplement Dates FDA Received: 09/01/2023; 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening