MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO LONG GEN / PRO 39 X 90 BIL 135; CATHETER, BILIARY, DIAGNOSTIC

Model Number	PG3990BPX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information is pending and will be sent in upon 30 days after receipt.
Event or Problem Description
As reported, the stent of a palmaz long genesis stent on.035" 39 x 90 x 135 opta pro balloon expandable stent delivery system dislodged before deploying in the wrong location in the patient¿s body.It resulted in patient having to have two unknown extra bilateral kissing stents to crush stent to vessel wall.The operator was trained to use the device.The device was opened in a sterile field.The device was stored on a shelf in the cath lab, for less than three months.The product was stored, handled and prepped per the instructions for use (ifu).There was no damage noticed to the device prior to opening the package.There was no difficulty removing the device from the sterile packaging.There were no kinks or other damages noted prior or after to inserting the product into the patient.The other devices used with the product did not kink or bend at any time.There was no kinks to any part of the device.There was nothing unusual noted about the stent delivery system prior to use.There was no unusual force used at any time during the procedure.There was no attempt made to recapture the stent.The target lesion was the iliac, with moderate calcification and moderate tortuosity.There was eighty percent stenosis.The device was not used for a chronic total occlusion (cto).Two kissing stents were deployed dislodged stent was crushed to side of vessel.Two non-cordis stents were used to complete the procedure.The patient is currently fine.The stent is not available for evaluation as it remains in the patient body.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2 and h6 have been updated accordingly.The stent of a palmaz long genesis stent on.035" 39 x 90 x 135 opta pro balloon expandable stent delivery system dislodged before deploying in the wrong location in the patient¿s body.It resulted in patient having to have two unknown extra bilateral kissing stents to crush stent to vessel wall.The target lesion was the iliac, with moderate calcification and moderate tortuosity.There was eighty percent stenosis.The operator was trained to use the device.The device was opened in a sterile field.The device was stored on a shelf in the cath lab, for less than three months.The product was stored, handled and prepped per the instructions for use (ifu).There was no damage noticed to the device prior to opening the package.There was no difficulty removing the device from the sterile packaging.There were no kinks or other damages noted prior or after to inserting the product into the patient.The other devices used with the product did not kink or bend at any time.There was no kinks to any part of the device.There was nothing unusual noted about the stent delivery system prior to use.There was no unusual force used at any time during the procedure.There was no attempt made to recapture the stent.The device was not used for a chronic total occlusion (cto).Two kissing stents were deployed dislodged stent was crushed to side of vessel.Two non-cordis stents were used to complete the procedure.The patient is currently fine.The product was not returned for analysis.A product history record (phr) review of lot 82208524 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent dislodged - in patient¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of moderate calcification and tortuosity and a rate of stenosis of 80% may have contributed to the reported event.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.¿ therefore, this is considered off label usage.Neither the phr nor the 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: LONG GEN / PRO 39 X 90 BIL 135
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 11604057
• Report Number: 9616099-2021-04381
• Device Sequence Number: 3544536
• Product Code: FGE
• UDI-Device Identifier: 20705032040201
• UDI-Public: 20705032040201
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K012590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: PG3990BPX
• Device Catalogue Number: PG3990BPX
• Device Lot Number: 82208524
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability