MAUDE Adverse Event Report: CORDIS CORPORATION LONG GEN / PRO 39 X 90 BIL 80; CATHETER, BILIARY, DIAGNOSTIC

Model Number	PG3990BPS
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
During or after use, it was reported that the stent came off the palmaz genesis on pro balloon prematurely and slid off.Vascular surgery was needed.There were no patient injury.The device is available for return.
Additional Manufacturer Narrative
During or after use, it was reported that the stent came off the palmaz genesis on pro stent delivery system (sds) prematurely and slid off.Vascular surgery was needed.The physician did a surgical cut down on the patient¿s right iliac artery to retrieve the stent.There were no patient injury.The lesion was very tight so physician tried to push the genesis stent through the stenosis.The lesion was calcified, no tortuosity with 90% stenosis.The device was prepped according to the instruction for use (ifu) with no difficulties noted during prep.There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.The device was not used for a chronic total occlusion (total occlusion >3 months).The catheter has never been in an acute bend.The stent was returned for analysis.A non-sterile stent from a long gen / pro 39 x 90 bil 80cm sds was returned for analysis, whereas the rest of the product (shaft and balloon) were not returned.Per visual analysis severe damage to the stent was noted from the middle to one of its ends; the middle section showed an even compression while an uneven compression was noted at one of its ends.No other anomalies were noted during visual analysis.Per microscopic analysis the damage detected visually was confirmed whilst no fractures or other damages were observed.No further analysis could be performed as the remainder of the device were not returned for analysis.A device history record (dhr) review of lot 17583536 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, vessel characteristics (the lesion was calcified, no tortuosity with a 90% stenosis) and procedural factors (the lesion was very tight so the physician tried to push the stent through the stenosis) may have contributed to the burst as evidenced by the compression damage noted on the stent during analysis.The palmaz genesis on opa pro sds for biliary usage is not recommended for vascular usage; therefore this is considered off-label usage.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.¿ neither the dhr review, the procedure films 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.

• Brand Name: LONG GEN / PRO 39 X 90 BIL 80
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 6807402
• Report Number: 9616099-2017-01341
• Device Sequence Number: 1568883
• Product Code: FGE
• UDI-Device Identifier: 20705032040195
• UDI-Public: 20705032040195
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K012590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PG3990BPS
• Device Catalogue Number: PG3990BPS
• Device Lot Number: 17583536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Distributor Facility Aware Date: 07/26/2017
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 09/22/2017
• Initial Report FDA Received Date: 08/21/2017
• Supplement Report FDA Received Date: 10/05/2017
• 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: Required Intervention