MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 9X40; STENT, CAROTID

Catalog Number PC0940XCE

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2017

Event Type  Injury  

Manufacturer Narrative

Please note that the product was returned for inspection and the preliminary comments indicated that the distal end was noted to be stretched.Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.The product was returned for evaluation and testing; however, the engineering evaluation is not complete.Additional information will be submitted within 30 days upon receipt.

Event Description

As reported, the tip of the precise pro rx 9 x 40 stent delivery system (sds) fell off during the procedure.Pictures are attached.The product will be returned for inspection.No additional information was provided.Additional information received indicated that the procedure was a carotid artery intervention/stent placement.The target lesion was the carotid artery.The lesion was reported to be: a seventy percent (70%) stenosis, and a little tortuous.The approach for the procedure was from the femoral artery.The reported distal tip separation of the complaint product occurred during stent deployment.The separated tip remained on the angioguard embolic protection device.No additional intervention was necessary to retrieve the separated distal tip.The separated distal tip was successfully removed from the patient without any patient injury.The precise stent was successfully deployed in the patient.The complaint product including the separated distal tip is being returned for inspection.There was no other product issue noted either at the account after the procedure or prior to shipping for inspection.The product was stored properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.The product was prepped properly according to the ifu.The device was prepped in the tray.The tuohy borst (hemostasis) valve was in the open position when received.It is not known if the tuohy borst valve was closed prior to removing the device from the tray.When removed from the tray, the stent was still constrained within the outer member/sheath.A stopcock was connected to the y-connector of the tuohy borst valve.There was no difficulty encountered flushing the stopcock.There was no reported difficulty encountered flushing the sds.There was no reported difficulty or resistance inserting the device into the patient.There was no reported difficulty or resistance advancing the device to the target lesion.There was no reported excessive force used at any time during the procedure and there was no reported withdrawal difficulty.No additional information is available.

Manufacturer Narrative

During a carotid artery interventional procedure, the tip of the precise pro rx 9 x 40 stent delivery system (sds) fell off during the procedure.The target lesion was the carotid artery.The lesion was reported to have seventy percent (70%) stenosis, and the vessel was tortuous.The approach for the procedure was from the femoral artery.The reported distal tip separation of the complaint product occurred during stent deployment.The separated tip remained on the angioguard embolic protection device.No additional intervention was necessary to retrieve the separated distal tip.The separated distal tip was successfully removed from the patient without any patient injury.The precise stent was successfully deployed in the patient.There was no other product issue noted either at the account after the procedure or prior to shipping for inspection.The product was stored properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.The product was prepped properly according to the ifu.The device was prepped in the tray.The tuohy borst (hemostasis) valve was in the open position when received.It is not known if the tuohy borst valve was closed prior to removing the device from the tray.When removed from the tray, the stent was still constrained within the outer member/sheath.A stopcock was connected to the y-connector of the tuohy borst valve.There was no difficulty encountered flushing the stopcock.There was no reported difficulty encountered flushing the sds.There was no reported difficulty or resistance inserting the device into the patient.There was no reported difficulty or resistance advancing the device to the target lesion.There was no reported excessive force used at any time during the procedure and there was no reported withdrawal difficulty.The product was returned for inspection.One non-sterile precise pro rx 9x40 unit was received coiled inside in plastic bag.The unit was deployed, the distal tip was separated and not received for analysis.The distal end of the coiled support member presented an unraveled\stretched condition, and also a kink was observed on the distal end of the inner member.Blood residuals were observed on the support member.No other damages/anomalies were observed on the unit.Sem analysis results showed that the catheter separation area presented material deformation and evidence of elongations and frayed edges; these characteristics suggests that the device was induced to stretching/pulling events that exceed the material yield strength prior to the tip separation.The molding parameters of the pull test for this lot was reviewed and no anomalies found.Calibration records for tip uv bonding were reviewed, and it was found that the tip uv bonding machines pressure controller was calibrated in a timely manner.The lot involved in the complaint was manufactured within the calibration dates.A review of the manufacturing documentation, nonconformance records, and excursions associated with lot 17622779 was performed and it was found that no defective units were rejected during the final assembly of this lot.No other incidents were noted that could be potentially related to the complaint reported.The reported failure by the customer as ¿distal tip - separated - in patient¿ was confirmed as the product was received with tip separation, and also support member distal section presented an unraveled condition.The exact cause of the failure experienced by the customer as well as the damages observed on the unit during the analysis could not be conclusively determined.However, procedural factors and handling process might have contributed to the reported complaint as the sem results that the device was induced to stretching/pulling events that exceed the material yield strength prior to the tip separation.According to the instructions for use ¿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 dhr review 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.

• Brand Name: PRECISE PRO RX 9X40
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6886130
• MDR Text Key: 87200568
• Report Number: 9616099-2017-01440
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: PC0940XCE
• Device Lot Number: 17622779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/31/2017
• Date Manufacturer Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening