MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL NITINOL STENT SYSTEM; SELF EXPANDING STENTS (FGE)

Catalog Number C08040MV

Device Problems Difficult or Delayed Positioning (1157); Material Frayed (1262); Difficult to Remove (1528); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2016

Event Type  Injury  

Manufacturer Narrative

Please note that the gender of the patient unknown.(b)(4).(b)(6).The device is available to be returned for analysis; however, it has not yet been received.A device history record (dhr) review and additional information are pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the smart control stent delivery system (sds) distal tip got stuck to the edge of ring like material of sfa artificial graft stent.During withdrawal, the customer used a snare to get the distal tip out of the ring material.The distal tip was reportedly torn.Another sds was not used to complete the procedure.There was no patient injury.The product was stored per labelling.The intended procedure was stent implantation at left anastomosis site.The stenosis rate was more than 70%; however, it is unknown the lesion was calcified or tortuous.It is unknown if the lesion was in an acute angle, bifurcating or angulated.For the procedure, an 8x40mm smart control sds was opened.There were no damages or anomalies noted to the device or packaging prior to use.The device was handled and prepped according to the instructions for use with no anomalies noted.After the guidewire crossed the lesion with some difficulty, the smart control was inserted into the patient.It is unknown if there was any difficulty advancing the device to through the vessel, or if the vessel was in an acute bend.However, the distal tip of the sds got stuck in the edge of a ring-like material of a sfa artificial stent graft.It is unknown if force was ever required when using the device or if the tip had separated.The customer used a snare to get the distal tip out of the ring material.The distal tip was reportedly torn.Another sds was not used to complete the procedure, however the stent had not been deployed.It is unknown how the procedure was completed.There was no patient injury.

Manufacturer Narrative

Complaint conclusion: a report was received that difficulty was experienced when removing an 8 x 40mm smart vascular stent delivery system (sds) from a previously implanted ¿artificial stent graft.¿ the site reported that the distal tip of the sds was removed from the ring material with snaring and became torn.The device was successfully removed and the procedure completed without further intervention and with no reported patient injury.The event involved a patient undergoing an endovascular percutaneous intervention of a target lesion in the superficial femoral artery (sfa).This lesion was described as more than 70% stenosed and located on the anastomosis on the left side of a stent graft.The patient¿s vasculature was accessed and a guidewire used to cross the lesion with some difficulty.The site reported that the smart device had been stored according to the instructions for use (ifu).No damages or anomalies were noted on the damage or its¿ packaging prior to use and had been handled and prepped according to the ifu without difficulty.The smart sds was advanced and appears that the distal tip of the catheter became stuck in the edge of a ring-like material of an sfa artificial stent graft.It is unclear from the report whether the distal tip of the sds separated from the catheter or not but is reported to have become torn.The device was removed (with an un-deployed stent) with the use of a snare and the procedure successfully completed with no further intervention and with no reported patient injury.The product was not returned for analysis despite multiple attempts to obtain it.A review of the manufacturing records for this lot of products revealed that it met specification prior to release.Of note, the expiration date of this product had been exceeded when this device was used.Without the return of the device for analysis, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.According to the product ifu, users are warned to use the device prior to the ¿use by¿ date specified on the package.It is difficult to draw a clinical conclusion between the device and the event based on the information available.However procedural factors (use of expired device and advancement of sds into previously implanted graft) may have contributed to it.Based on the device history record review, there is no indication that the event was related to the manufacturing process.Therefore, no corrective actions will be taken at this time.

Manufacturer Narrative

The device was received for analysis.Section was updated accordingly.However, the engineering report is not yet available, but it will be submitted within 30 days upon receipt.Additional information was received: the device was returned with the stent deployed 0.5 cm.It is unknown if it was noted that the stent was partially deployed when it was removed from the patient.It is unknown if the physician attempted to deploy the stent outside of the patient.It is unknown if it was confirmed that the stent was fully contained in the device when removed from the patient.No other information is known.(b)(4).

Manufacturer Narrative

Complaint conclusion: a report was received that difficulty was experienced when removing an 8 x 40mm smart vascular stent delivery system (sds) from a previously implanted ¿artificial stent graft¿.The site reported that the distal tip of the sds was removed from the ring material with snaring and became torn.The device was successfully removed and the procedure completed without further intervention and with no reported patient injury.The event involved a patient undergoing an endovascular percutaneous intervention of a target lesion in the superficial femoral artery (sfa).This lesion was described as more than 70% stenosed and located on the anastomosis on the left side of a stent graft.The patient¿s vasculature was accessed and a guidewire used to cross the lesion with some difficulty.The site reported that the smart device had been stored according to the instructions for use (ifu).No damages or anomalies were noted on the damage or its¿ packaging prior to use and had been handled and prepped according to the ifu without difficulty.The smart sds was advanced and appears that the distal tip of the catheter became stuck in the edge of a ring-like material of an sfa artificial stent graft.It is unclear from the report whether the distal tip of the sds separated from the catheter or not but is reported to have become torn.The device was removed (with an un-deployed stent) with the use of a snare and the procedure successfully completed with no further intervention and with no reported patient injury.One non-sterile unit pkg assy 8x040 smart vas120cm was received coiled inside a plastic bag with a partially deployed stent (by 4cm).The hemostasis valve in its¿ original position and the locking pin was noted to be loose.The device outer body was separated 3cm from the id band.In addition, the distal tip of the sds was noted to be frayed.No other anomalies/damages were found during the visual analysis.Dimensional analysis of the usable length and functional testing of the deployment process could not be performed because of the condition of the returned product.Sem analysis of the outer body separation revealed evidence of catheter body elongation.Sem analysis of the frayed distal tip also revealed evidence of elongation at the areas surrounding the frayed condition.These findings are suggestive of an application of tensile force and stress that exceeded the material yield strength that induced the separation.These characteristics suggest pulling\stretching events.No other issues were found during sem analysis.A review of the manufacturing records for this lot of products revealed that it met specification prior to release.Of note, the expiration date of this product had been exceeded when this device was used.The reported ¿sds - deployment difficulty-premature deployment¿, ¿catheter tip - frayed/split/torn-in patient¿ and ¿ sds- withdrawal difficulty-snagged/caught on stent ¿events were confirmed based on the visual analysis.However, it¿s very likely that these events could be related to the outer member separation and the frayed distal tip on the returned device.The exact cause of these events could not be conclusively determined.However, it is possible that procedural/handling factors may have contributed them.According to the product ifu, users are warned to use the device prior to the ¿use by¿ date specified on the package.Based on the information available for review, there are procedural factors (use of expired device, advancement of sds into the previously implanted graft and based on the results of the analysis of the returned product) that may have contributed to the reported events.Neither the device history record review nor the product analysis suggests that the reported event was related to the manufacturing process.Therefore, no corrective actions will be taken at this time.

• Brand Name: SMART CONTROL NITINOL STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS (FGE)
• 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: 5462088
• MDR Text Key: 39078697
• Report Number: 9616099-2016-00101
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: KN
• PMA/PMN Number: K021898
• 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,Followup
• Report Date: 02/03/2016

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: 12/31/2015
• Device Catalogue Number: C08040MV
• Device Lot Number: 16053450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2016
• Initial Date FDA Received: 02/25/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/16/2016; 04/26/2016; 06/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention