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

Model Number	LSMU1350526
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2017
Type of Reportable Event	Malfunction
Additional 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 currently in progress.
Event or Problem Description
It was reported that the stent dislodged from the device when attempting to pull it back through the sheath.A 6.5f medtronic tour guide introducer sheath was used.The target lesion was the sma.The complaint device was prepped correctly and delivered to the target lesion over a 0.035 guidewire.The doctor decided that a stiffer guidewire would be required for deployment so an attempt was made to retract the lifestream device.When the catheter was being backed out of the sheath the stent dislodged from the balloon completely.It was half way out of the valve and was visible to remove.Another lifestream device was used with the new guidewire in the sma and the procedure was a success.There was no harm to the patient.
Additional Manufacturer Narrative
It was reported that the stent dislodged from the device when attempting to pull it back through the sheath.A 6.5f medtronic tour guide introducer sheath was used.The target lesion was the sma.The complaint device was prepped correctly and delivered to the target lesion over a 0.035 guidewire.The doctor decided that a stiffer guidewire would be required for deployment so an attempt was made to retract the lifestream device.When the catheter was being backed out of the sheath the stent dislodged from the balloon completely.It was half way out of the valve and was visible to remove.Another lifestream device was used with the new guidewire in the sma and the procedure was a success.There was no harm to the patient.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.No packaging was returned.The hub was printed as expected.A white substance was noted in the guidewire lumen of the hub.The substance type is unknown.The sleeve was not returned no visual defects were noted on the tip, balloon, inner or outer.The stent was returned positioned between the two markerbands.The stent was slightly curved closed to the distal markerband.The stent was secure on the balloon.An attempt was made to insert a 0.035" guidewire through the returned device, however the attempt was unsuccessful, due to a blockage noted in the guidewire lumen of the hub.The guidewire was re-inserted through the tip of the device and this was also unsuccessful due to another blockage 70mm from the distal tip.Subsequent to this a 0.014" guide wire was inserted through the device from the hub end.However, the guide wire was unable to pass through the blockage noted 70mm from the tip.The guide wire was removed and dried blood was noted on the wire and exit of hub.The blockage was believed to be dried blood.With a 0.014" guide wire inserted into the device to approx.70mm from the tip, the device was inserted into own 6f terumo sheath.During the process of insertion a number of kinks occurred on the outer (due to partial absence of guide wire).However the device was inserted fully.The stent did not dislodge.The result of the investigation is unconfirmed for the reported failure mode of stent dislodged.During the evaluation, the returned device was inserted into a 6f terumo sheath without the stent becoming dislodged.The stent remained secure in the correct position on the balloon.Even though the event is unconfirmed it should be noted that user error and procedural techniques occurred during the procedure.The event description states that the stent dislodged from the device when attempting to pull it back through the sheath.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".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 oct 17 is (b)(4).While this figure is slightly higher than the predicted rate of (b)(4) this calculation is based on 14 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: 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
• Common Device Name: BALLOON EXPANDABLE VASCULAR COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• MDR Report Key: 7085962
• Report Number: 9616666-2017-00140
• Device Sequence Number: 1874759
• Product Code: PRL
• UDI-Device Identifier: 05391522080980
• UDI-Public: (01)05391522080980
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P160024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: LSMU1350526
• Device Catalogue Number: LSMU1350526
• Device Lot Number: CMBP0099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR