MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX CAROTID STENT SYSTEM; SELF EXPANDING STENTS

Catalog Number PC0840XCE

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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, when pulling back the shaft of the 135 cm.5 fr.Precise pro rx 8 x 40 stent delivery system (sds), it broke about twenty-three (23) cm.From the tip.The stent was still on the shaft and was not deployed.There was no reported patient injury.The physician is an experienced used of the device.The product will be returned for inspection.Additional information received indicated that it was the catheter body/stent delivery system that broke/separated.A more specific component description was not provided.The separated piece remained on the unknown guidewire used.No additional intervention was necessary to remove the separated piece.There were no reported ill effects to the patient/no reported patient injury.The entire product including the stent and separated piece are being returned for inspection.The procedure was stopped at this time without stent placement as the physician had wanted to extend the unknown stent that was already implanted previously some time ago.There was no reported restenosis of the previously implanted stent.The physician just wanted to extend the stent.No target lesion/lesion characteristic information was provided.The approach for the procedure was no provided.There was no damage noted to the product packaging upon inspection prior to opening.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 instructions for use (ifu) with no problems noted.No additional information is available.

Manufacturer Narrative

A quality review board was held to review this event on april 21st, 2016.At that time the decision was made to execute a voluntary recall of 173 lots of the precise pro carotid stent and 5 lots of the precise biliary stent.This medwatch serves as the required 5-day report.Additional information will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: a report was received that the shaft of a 5fr 8 x 40mm precise pro ous carotid system broke and that the stent did not deploy.The device was removed intact with no reported patient injury.The event involved a patient undergoing a percutaneous intervention on an unspecified target lesion.The physician¿s plan was to place the precise stent close to a previously placed non-restenotic precise stent.The site reported that no damage was noted to the packaging prior to opening the stent delivery system (sds) and no difficulty experienced when removing the device from the packaging.The product was inspected prior to use and appeared normal.The device was prepped according to the instructions for use (ifu) without issue.When retracting the shaft of the sds, the site noted that it broke approximately 23cm from the tip and the stent did not deploy.The entire device was removed intact with no additional intervention and no reported patient injury.The physician is reported to be an experienced user of this device.One non sterile unit precise pro rx us carotid syst cm was received coiled inside a plastic bag with an un-deployed stent and the hemostasis valve open.In addition, the outer body was noted to be separated 20 cm from the brite tip.No other damages were found on the received unit.Functional deployment testing and dimensional analysis of the stroke length could not be performed due the condition of the returned device.Sem analysis of the separated sections of the outer member revealed evidence of elongation, plastic deformation and frayed edges suggestive of an application of tensile force inducing the separation.No other issues were noted during the sem analysis.A review of the manufacturing records for this lot of products revealed that it met specification prior to release.The reported ¿sds - deployment difficulty-unable¿ and ¿sds ¿ separated-in patient¿ events were confirmed based on the results of the visual analysis.This event is most likely related to the observed outer body separation.The exact cause of the separation found on the received precise could not be conclusively determined during the analysis.According to the product ifu, users are instructed to ensure that the sds outside the patient remains flat and straight.Users are instructed to unlock the hemostasis valve prior to stent deployment.They are to ensure that the sheath introducer or guiding catheter does not move during deployment.The ifu further instructs users to initiate stent deployment by retracting the outer sheath while holding the inner shaft in a fixed position.Deployment is complete when the outer sheath marker passes the proximal inner shaft stent marker.It is difficult to draw a clinical conclusion between the device and the event based on the information available.However, based on the results of the sem analysis, procedural factors may have contributed to it.A risk assessment and investigation has been initiated to address these types of issues.

• Brand Name: PRECISE PRO RX CAROTID STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5549007
• MDR Text Key: 41940269
• Report Number: 9616099-2016-00171
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: PC0840XCE
• Device Lot Number: 17279782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1