MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX NITINOL STENT SYSTEM; STENT, CAROTID

Model Number N/A

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/16/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 8f terumo sheath introducer.8f boston guiding catheter.Abbott 0.035¿armada 6mm*4mm.(b)(6).The device was returned but the engineering report is pending.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

A 10 x 30 precise pro rx carotid self-expanding stent (ses) stent released in the patient while accessing the femoral artery puncture site and deployed in the femoral artery which led to a massive hemorrhage.The physician removed the delivery system and performed compression hemostasis for the puncture point.Then a large size balloon was used to block the blood flow and the stent was removed.The artificial blood vessel was used for the following hemostasis which was completed successfully.No further procedure was done for the left subclavian so there was no another stent to treat the left subclavian.The intended procedure was to treat the left subclavian stenosis.The 50% occluded target lesion was 26mm in length in a 9mm vessel diameter.There was no calcification or vessel tortuosity.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was stored, handled, inspected and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.Delivery of the sds to the lesion was contralateral.There was no unusual force used at any time during the procedure.There was no thrombus present proximal to, at, or distal to the lesion site.The lesion pre-dilated prior to stent implantation at 9 atmospheres (atm) using a non-cordis balloon catheter.The device will be returned for evaluation.

Manufacturer Narrative

A precise pro rx 10 x 30 carotid self-expanding stent (ses) stent released in the patient while accessing the femoral artery puncture site and deployed in the femoral artery which led to a massive hemorrhage.The physician removed the delivery system and performed compression hemostasis for the puncture point.Then a large size balloon was used to block the blood flow and the stent was removed.The artificial blood vessel was used for the following hemostasis which was completed successfully.No further procedure was done for the left subclavian so there was not another stent used to treat the left subclavian.The intended procedure was to treat the left subclavian stenosis.The 50% occluded target lesion was 26mm in length in a 9mm vessel diameter.There was no calcification or vessel tortuosity.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was stored, handled, inspected and prepped according to the instructions for use (ifu).There was nothing unusual noted about the stent delivery system prior to use.Delivery of the sds to the lesion was contralateral.There was no unusual force used at any time during the procedure.There was no thrombus present proximal to, at, or distal to the lesion site.The lesion pre-dilated prior to stent implantation at 9 atmospheres (atm) using a non-cordis balloon catheter.The product was returned for analysis.One non-sterile precise pro rx 10x30, stent delivery system was received for analysis inside a plastic bag.No original packaging was returned.The valve of the unit was received locked/ closed.Per visual analysis, the unit was received already deployed.No stent was received or returned for analysis.The body shaft of the stent delivery system was observed kinked at 3.0 cm from the brite tip at the distal area and also, it was observed accordioned/ twisted damaged at 8.0 cm from the id band at the proximal area of the unit.Additionally, the hypo tube of the unit was observed severely bent, damaged.No other anomalies were found.Per functional analysis, the tuohy borst valve of the stent delivery system was unlocked, and the stent deployment test was simulated by retracting the outer sheath.The deployment test was successfully simulated; the inner shaft was exposed as it would be expected under normal deployment conditions.Per dimensional analysis, the usable length of the unit was measured and found within specification.A product history record (phr) review of lot 17898149 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 - premature deployment¿ was not confirmed.The unit could not be properly evaluated since the precise pro rx 10x30 stent delivery system was received already with the stent deployed (the stent was not returned for evaluation).However, the body shaft was observed kinked, accordioned/ twisted damaged.The hypo tube was also observed severely bent/damaged.Neither the cause of the reported ¿deployment difficulty - premature deployment¿ nor the cause of the observed damaged conditions on the unit could be conclusively determined during the analysis.The unit was successfully measured and functionally tested.No obvious indication of product-related failure was found.Per the observed conditions of the device, it could be suggested that procedural factors and or handling factors such as the user¿s interaction with the device as noted in the device analysis (kinked, accordioned/twisted, severely bent/ damaged) may have led to the reported events.Additionally, it can be assumed that while accessing the femoral artery puncture site, the user¿s interaction with the device may have caused the reported hemorrhage as evidence by the product analysis and the condition of the returned unit, as received.Risks associated with stenting procedures include hemorrhage (hemorrhage was specifically reported).These are well-known and extensively documented potential complication of this type of procedure and is listed in the instructions for use (ifu) as such.According to the instructions for use ¿note: if resistance is met during delivery system introduction, the system should be withdrawn, and another system should be used.Overstretching of the artery may result in rupture and life-threatening bleeding.¿ additionally, the instructions for use (ifu) advises to ¿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.¿ the phr review nor the product analysis suggests that the reported events could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: PRECISE PRO RX NITINOL STENT SYSTEM
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10677115
• MDR Text Key: 211456171
• Report Number: 9616099-2020-03979
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036556
• UDI-Public: 20705032036556
• Combination Product (y/n): N
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: PC1030XCE
• Device Lot Number: 17898149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 73