MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. LIFESTREAM; BALLOON EXPANDABLE VASCULAR COVERED STENT

Model Number LSMU1350626

Device Problems Physical Resistance (2578); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/27/2017

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was received.The investigation is on-going.

Event Description

It was reported that the stent dislodged inside of the sheath.A 90 cm, 6fr, terumo destination sheath was used.The target lesion was the coronary artery, close to the aortic arch.Access was made via the common femoral artery.Pre dilatation was performed.A lifestream device was delivered to the deployment site, passing through the entirety of the sheath.However upon inspection, dr.Fernandez judged that the stent needed to be placed in a different position, which called for a different sheath position.Therefore, the lifestream device unit was then withdrawn out of the patient fully intact.The sheath was repositioned and the device was re-delivered.Once out of the distal end of the sheath, it was noted the stent-graft was no longer mounted on the balloon.An angiographic image showed the stent graft lodged inside the distal portion of the sheath.The sheath was withdrawn and the stent was retrieved.A second sheath, this time a 6.5fr medtronic steerable tourguide sheath was selected and placed.The complaint device was to be used.However, again the stent-graft was found dislodged from the balloon and lodged in the distal portion of the sheath, confirmed under fluoroscopy.The delivery system and implant were removed with the sheath and the stent graft was retrieved.The stent was protected by the sheath during all steps of tracking.The device was pulled back into the sheath during the procedure.Resistance was felt when tracking.Air evacuation was not performed.A bare metal express stent was then selected and placed in the treatment site.Guidewire access was maintained throughout the procedure.There was no reported patient injury.

Manufacturer Narrative

It was reported that the stent dislodged inside of the sheath.A 90cm, 6fr, terumo destination sheath was used.The target lesion was the coronary artery, close to the aortic arch.Access was made via the common femoral artery.Pre dilatation was performed.A lifestream device was delivered to the deployment site, passing through the entirety of the sheath.However upon inspection, dr.Fernandez judged that the stent needed to be placed in a different position, which called for a different sheath position.Therefore, the lifestream device unit was then withdrawn out of the patient fully intact.The sheath was repositioned and the device was re-delivered.Once out of the distal end of the sheath, it was noted the stent-graft was no longer mounted on the balloon.An angiographic image showed the stent graft lodged inside the distal portion of the sheath.The sheath was withdrawn and the stent was retrieved.A second sheath, this time a 6.5fr medtronic steerable tour guide sheath was selected and placed.The complaint device was to be used.However, again the stent-graft was found dislodged from the balloon and lodged in the distal portion of the sheath, confirmed under fluoroscopy.The delivery system and implant were removed with the sheath and the stent graft was retrieved.The stent was protected by the sheath during all steps of tracking.The device was pulled back into the sheath during the procedure.Resistance was felt when tracking.Air evacuation was not performed.A bare metal express stent was then selected and placed in the treatment site.Guidewire access was maintained throughout the procedure.There was no reported patient injury.The lot history records have been reviewed with special attention to the manufacturing and inspection of this product.The device was found to have met specifications prior to shipment.No manufacturing anomalies were identified that may have caused or contributed to the reported event.This is the first reported complaint for this lot number and issue to date.The device was returned for evaluation.External and internal packaging was returned.The hub was printed as expected and there were no visual defects noted.The stent guard was not returned with the device.No visual defects were noted on the tip or outer.The inner at the balloon was slightly curved / bowed.The stent was returned separate to the device.It was curved & slightly flattened.The ptfe coating was slightly pulled back at one end.There was evidence to suggest that the balloon had been previously inflated.There was evidence of clear substance inside the balloon.No functional examination was carried out on the device as it was not applicable to the complaint.The evaluation result of the returned device is confirmed for the stent dislodgement failure mode reported.The stent was returned separate to the device.The balloon had been inflated.The event information described that the lifestream device was delivered to the deployment site been the coronary artery.This indicates that the device was been used off label.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries.User error and procedural techniques may also have been contributing factors.Air evacuation was not performed.The event description states that the device was pulled back into the sheath during the procedure.This is contrary to what is directed in the ifu.The ifu states "attempting to remove an unexpanded covered stent by pulling it back into the sheath/guiding catheter may result in the stent dislodgment".The event description also states that the "lifestream device unit was then withdrawn out of the patient fully intact.The sheath was repositioned and the complaint device was re-delivered".This is contrary to what is directed in the ifu.The ifu states "do not attempt to remove an unexpanded covered stent through the sheath /guiding catheter".Based upon the available information a definitive root cause cannot be determined.Based on analysis performed no additional action is required at this time.Note: while the current confirmed calculated occurrence rate for this failure mode is (b)(4) (last 24 months) and is hence higher than the predicted rate of (b)(4) the rate is decreasing since the process improvement (action from capa) was introduced into production during sept 16.The current rate from sept 16 to sept 17 is (b)(4).While this figure is slightly higher than the predicted rate of (b)(4) this calculation is based on 13 months of sales which is less than the required 24 months.If the calculation is adjusted for 24 months sales the rate is 0.01% which is equal to the predicted rate.The ifu states: a device description/ implant: the lifestream¿ balloon expandable vascular covered stent is comprised of an electropolished balloon-expandable stent made from 316l stainless steel, encapsulated between two layers of eptfe.Indication for use: the lifestream¿ balloon expandable vascular covered stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries.Directions for use: site access and preparation: using standard techniques access the artery and place an introducer sheath or guiding catheter of appropriate inner diameter and a 0.035" (0.89 mm) guidewire across the target lesion.Perform diagnostic angiography to confirm site of implantation and measure the reference vessel diameter and lesion length.Covered stent size selection select a covered stent diameter that is approximately 5%-20% larger than the largest reference vessel diameter at the proximal or distal target site.Refer to the sizing table on the packaging label for appropriate selection of the covered stent diameter and length.Endovascular system preparation carefully remove the selected device from the package.Inspect the covered stent for adherence to the balloon and centered placement in relation to the balloon marker bands.If the covered stent is not centered and/or does not firmly adhere to the balloon, do not use.Flush the delivery system guidewire lumen with sterile saline mixture until saline drops from the distal end of the endovascular system.Air evacuation a 20 cc or smaller luer-lock syringe with a minimum of 5 cc¿s sterile saline mixture is recommended for use for aspirating this device.With the distal balloon tip pointing down and positioned below the level of the syringe, pull negative pressure until all air is expelled.Induce a negative pressure to remove any air from the balloon and inflation lumen.Repeat until all air is expelled.Carefully release to neutral.Allow the inflation lumen to fill with the diluted contrast medium and maintain a neutral pressure.Important: do not apply positive pressure to the balloon.Attach the prefilled inflation device to the inflation lumen of the catheter hub, ensuring no air bubbles remain at the catheter connection.Verify that the covered stent is still centered between the two radiopaque markers on the balloon catheter.Introduction of the endovascular system and placement of the covered stent advance the endovascular system over the guidewire into the introducer sheath.Further advance the endovascular system to the target treatment site within the introducer sheath and position the covered stent across the lesion.Verify that the covered stent is still centered within the balloon marker bands.Slowly retract the introducer sheath / guiding catheter while maintaining the position of the covered stent.Ensure the introducer sheath is retracted far enough to not compromise the balloon expansion and covered stent release.(b)(4).

• Brand Name: LIFESTREAM
• Type of Device: BALLOON EXPANDABLE VASCULAR COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• Manufacturer Contact: fiona nimhullain ; 539237111
• MDR Report Key: 6998585
• MDR Text Key: 92327986
• Report Number: 9616666-2017-00112
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081055
• UDI-Public: (01)05391522081055
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

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: 04/30/2020
• Device Model Number: LSMU1350626
• Device Catalogue Number: LSMU1350626
• Device Lot Number: CMBS0370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/04/2017
• Initial Date FDA Received: 11/03/2017
• Supplement Dates Manufacturer Received: 10/31/2017
• Supplement Dates FDA Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2017
• 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