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

Model Number PC0740XCE

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 09/05/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18030860 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, a 7*40 precise stent was stuck and could not be released fully after releasing two segments during the release process.No patient injury was reported.The temperature exposure indicator on the pouch was checked and confirmed that the black dotted pattern with a grey background was clearly visible.The product was stored and handled properly according to the instructions for use (ifu).The device was inspected and prepped per the ifu.The device was prepped in the tray.There was nothing unusual noted about the stent delivery system prior to use.The tuohy borst was received in the open position.The stent was constrained within the outer member/sheath after removal from the tray.A stopcock was connected to the y-connector of the tuohy borst valve.No difficulty was encountered while flushing the stopcock.An 8f guiding sheath was used in the vessel.The intended lesion/target was in the internal carotid artery with a 80% stenosis.The lesion was at the carotid bifurcation.The lesion was measured to be 6mm.The diameter of the unconstrained stent size was 1-2mm larger than the vessel diameter.The target lesion was measured to be 35mm in length.The lesion had moderate calcification and the vessel was noted to have moderate tortuosity.There was no resistance/friction while advancing the sds through the vessel.There was no difficulty while crossing the lesion.The delivery system did not pass through any acute bends.The user maintained a fixed inner shaft position during deployment.Unusual force was not applied while deploying the stent.The stent was attempted to be re-captured; however, the physician was able to advance the sheath over the 2 deployed segments.The stent was then recovered/removed.The case was completed after switching to a non-cordis stent.The device will be returned for evaluation.

Manufacturer Narrative

A precise 7 x 40 stent was stuck and could not be released fully after releasing two segments during the release process.The temperature exposure indicator on the pouch was checked and confirmed that the black dotted pattern with a grey background was clearly visible.The product was stored and handled properly according to the instructions for use (ifu).The device was inspected and prepped per the ifu.The device was prepped in the tray.There was nothing unusual noted about the stent delivery system prior to use.The tuohy borst was received in the open position.The stent was constrained within the outer member/sheath after removal from the tray.A stopcock was connected to the y-connector of the tuohy borst valve.No difficulty was encountered while flushing the stopcock.An 8f guiding sheath was used in the vessel.The intended lesion/target was in the internal carotid artery with an 80% stenosis.The lesion was at the carotid bifurcation.The lesion was measured to be 6mm.The diameter of the unconstrained stent size was 1-2mm larger than the vessel diameter.The target lesion was measured to be 35mm in length.The lesion had moderate calcification and the vessel was noted to have moderate tortuosity.There was no resistance/friction while advancing the sds through the vessel.There was no difficulty while crossing the lesion.The delivery system did not pass through any acute bends.The user maintained a fixed inner shaft position during deployment.Unusual force was not applied while deploying the stent.The stent was attempted to be re-captured; however, the physician was able to advance the sheath over the 2 deployed segments.The stent was then recovered/removed.The case was completed after switching to a non-cordis stent.No patient injury was reported.The device was returned for analysis.One non-sterile precise pro 7x40 rapid exchange (rx) self-expanding stent (ses) delivery system was received for analysis inside a plastic bag.The valve of the unit was received partially open.Per visual analysis, the stent of the unit was received 0.4 cm partially deployed.The shaft of the unit was found kinked at 14.4 cm from the id band.Also, a bent damage could be observed on the stroke length pusher rod of the unit.No other anomalies found.Per functional analysis, a deployment test was performed on the unit despite the bent and kinked condition of the unit the way it was received for evaluation.The tuohy borst valve of the stent delivery system was fully open, and the stent deployment test was successfully performed by retracting the outer sheath while holding the inner shaft in a fixed position.The stent was fully unsheathed/expanded as expected.No anomalies found.Per dimensional analysis, the usable length of the stent delivery system was measured against the precise pro rx packaging assembly specification, and it was found within specification.A product history record (phr) review of lot 18030860 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent delivery system (sds)-ses-deployment difficulty - partial deployment¿ was confirmed since the stent of the unit was received 0.4 cm partially deployed the way it was received for analysis.However, a kinked and bent condition on the unit was observed.Nonetheless, neither the cause of the kinked and bent condition nor the observed partially deployed stent of the unit could be conclusively determined during the product analysis.Procedural and or handling factors such as the user¿s interaction with the device during use as well as vessel characteristic of a moderately calcified lesion with moderate tortuosity and 80% stenosis may have contributed to the reported event as well as the noted kinked and bent condition of the device, as received.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.Note: if resistance is met during delivery system introduction, the system should be withdrawn, and another system should be used.Note: if any resistance is met during delivery system withdrawal, advance the outer sheath until the outer sheath marker contacts the catheter tip and withdraw the system as one unit.¿ neither the phr review nor the product analysis suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: PRECISE PRO RX 7X40
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 12564747
• MDR Text Key: 274533759
• Report Number: 9616099-2021-04903
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032052395
• UDI-Public: (01)20705032052395(17)230531(10)18030860
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: PC0740XCE
• Device Catalogue Number: PC0740XCE
• Device Lot Number: 18030860
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/06/2021
• Initial Date FDA Received: 10/01/2021
• Supplement Dates Manufacturer Received: 10/27/2021
• Supplement Dates FDA Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 59