MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 7X40; STENT, CAROTID

Catalog Number PC0740XCE

Device Problems Difficult or Delayed Positioning (1157); Material Frayed (1262); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/19/2018

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot 17715279 presented no issues during the manufacturing process that can be related to the reported complaint.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, 7x40 precise pro rx stent did not deploy as it was unable to expand.An unknown event occurred that required intervention to prevent permanent impairment or damage.The device was stored in the lab as indicated by the manufacturer and the device was stored and handled per the instructions for use (ifu).There were no anomalies noted when removed from the package.The device did not separate when trying to be used.The device was used inside the patient.The procedure was completed with the same similar product.As per product analysis and per visual inspection, one separation condition was observed at 21 cm from the distal tip.Elongations and frayed edges could be observed on the separated outer member of the unit.A kinked/bent condition was noticed at 45 cm from the distal tip.Also, the pusher rod showed a kinked condition at 6 cm from the proximal end.The stent of the unit was not deployed, and the hemostasis valve was received open.Per microscopic analysis, the precise pro rx 7x40 body shaft separation was observed and elongations and frayed edges characteristics were confirmed on the outer member separated sections of the unit.The elongations and frayed edges observed on the separated outer member of the unit presented evidence of an application of a tension force that induced the outer member separation.

Manufacturer Narrative

After further review of product evaluation received the following sections g4, g7, h2, and h6 have been updated accordingly.Code 1262/material frayed is no longer applicable.During an unknown procedure, a 7x40 precise pro rx stent did not deploy the patient.An unknown event occurred that required intervention to prevent permanent impairment or damage.The procedure was completed with a similar device.The device was stored in the lab as indicated by the manufacturer and the device was stored and handled per the instructions for use (ifu).There were no anomalies noted when the device was removed from the package.The device did not separate when trying to be used.Multiple attempts were made for additional information, however no additional information was reported.The device was returned for analysis.A non-sterile precise pro rx 7x40 was received inside of a clear plastic bag.Per visual analysis, dried blood residue was noted on the device.A separated condition was noted at 21 cm from the distal tip.Elongations and frayed edges were noted on the separated outer member of the device.A kinked/bent condition was noted at 45 cm from the distal tip.Also, the pusher rod showed a kinked condition at 6 cm from the proximal end.The stent of the device was not deployed, and the hemostasis valve was received open.No other damages or anomalies were noted.Per microscopic analysis, a body shaft separation was observed under the fal vision system.Elongations and frayed edges were confirmed on the separated outer member sections of the device, these conditions presented with evidence of an application of a tension force that induced the outer member separation.Dimensional analysis was performed to verify the inner diameter (id) and outer diameter (od) of the outer sheath and were found within specification.A functional test was unable to be carried out due to the separation condition of the outer sheath.A product history record (phr) review of lot 17715279 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The phr review does not suggest that the event reported by the customer could be related to the manufacturing process.The reported ¿stent delivery system (sds)-ses deployment difficulty ¿ unable¿ was not confirmed due to the outer sheath separated condition on the received device.The functional test was unable to be performed due to the separated condition.The reported ¿outer sheath- separated¿ was confirmed.An outer sheath separation condition was noted.Dimensional analysis results were found within specification thus the exact cause of the separated condition of the device could not be conclusively determined during analysis.The reported ¿body/shaft- separated¿ was confirmed.A separated condition was noted at the body/shaft of the received device.The exact cause of the body/shaft separation could not be conclusively determined during analysis.The reported ¿stent delivery system- kinked/bent¿ was confirmed, a kinked/bent condition was noted at 45 cm from the distal tip.The exact cause of the reported events could not be conclusively determined during the analysis.Vessel characteristics, while unknown, as well as procedural and handling factors may have contributed to the reported events.According to the instructions for use (ifu), ¿extract the stent delivery system from the tray.Examine the device for any damage.Evaluate the distal end of the catheter to ensure that the stent is contained within the outer sheath.Do not use if the stent is partially deployed.If a gap between the catheter tip and outer sheath tip exists, open the tuohy borst valve and gently pull the inner shaft in a proximal direction until the gap is closed.Lock the tuohy borst valve after the adjustment by rotating the proximal valve end in a clockwise direction.If resistance is met during delivery system introduction, the system should be withdrawn, and another system used.¿ neither the phr review nor the product analysis suggest that the reported events could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: PRECISE PRO RX 7X40
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8227849
• MDR Text Key: 132409461
• Report Number: 9616099-2019-02627
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: PC0740XCE
• Device Lot Number: 17715279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Date Manufacturer Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 60