MAUDE Adverse Event Report: 8X40MM PRECISE PRO RX NITINOL STENT SYSTEM; STENT, CAROTID

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/01/2021

Event Type  Injury  

Manufacturer Narrative

The device remains implanted and is not available for analysis.Procedural films were provided.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, an 8mm x 40mm precise pro carotid self-expanding stent (ses) delivery system was deployed in the presence of a 95% stenosis and was post dilated with a 5mm x 30mm non-cordis percutaneous transluminal angioplasty (pta) balloon catheter; however, images of post dilation revealed stent fracture.The fracture was treated with a 7x15mm balloon expandable coronary stent placed across the strictured segment of the deployed right ica stent.There was good coverage of the fractured area with improvement in the stenosis at the right ica origin.A right carotid artery stenting procedure was being performed in the internal carotid artery (ica) at a carotid bifurcation.The 95% occluded lesion was 30mm in length in a 6.85mm in diameter the common carotid and 3.78mm in diameter in the ica.The lesion was calcified but there was no vessel tortuosity.The precise stent was stored, handled, inspected and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.A 6f non-cordis sheath was used in the procedure.The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.The stent delivery system did not pass through any acute bends.Delivery of the sds to the lesion was ipsilateral.There was no difficulty encountered while advancing/tracking the sds towards the lesion.There was no unusual force used at any time during the procedure.There was no thrombus present proximal to, at, or distal to the lesion site.The lesion was not pre-dilated prior to stent implantation.There was no difficulty or resistance noted while crossing the lesion with the stent.The sds did not have to pass through a previously placed stent.The stent expanded fully with good wall apposition.The device will not be returned for evaluation as it was implanted.

Manufacturer Narrative

A precise pro carotid self-expanding stent (ses) 8mm x 40mm delivery system was deployed in the presence of a 95% stenosis and was post dilated with a 5mm x 30mm non-cordis percutaneous transluminal angioplasty (pta) balloon catheter; however, images of post dilation revealed stent fracture.The fracture was treated with a 7x15mm balloon expandable coronary stent placed across the stricture segment of the deployed right ica stent.There was good coverage of the fractured area with improvement in the stenosis at the right ica origin.A right carotid artery stenting procedure was being performed in the internal carotid artery (ica) at a carotid bifurcation.The lesion was 30mm in length in a 6.85mm in diameter the common carotid and 3.78mm in diameter in the ica.The lesion was calcified but there was no vessel tortuosity.The precise stent was stored, handled, inspected and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.A 6f non-cordis sheath was used in the procedure.The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.The stent delivery system did not pass through any acute bends.Delivery of the sds to the lesion was ipsilateral.There was no difficulty encountered while advancing/tracking the sds towards the lesion.There was no unusual force used at any time during the procedure.There was no thrombus present proximal to, at, or distal to the lesion site.The lesion was not pre-dilated prior to stent implantation.There was no difficulty or resistance noted while crossing the lesion with the stent.The sds did not have to pass through a previously placed stent.The stent expanded fully with good wall apposition.The device was not returned for analysis.A product history record (phr) review of lot 18018573 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported events.Without the return of the device for analysis the reported ¿stent-ses~ fractured - in patient¿ was not confirmed.Additionally, no images nor procedural films were provided for evaluation.It is difficult to draw a clinical conclusion between the device and the events based on the information available.However, it is probable that procedural and or handling factors such as the user¿s interaction with the device and vessel characteristics of a 95% stenosed lesion may have contributed to the reported events.According to the instructions for use (ifu) ¿post-deployment stent dilatation: while using fluoroscopy, withdraw the entire delivery system as one unit, over the guidewire and out of the body.Remove the delivery device from the guidewire.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.(do not remove guidewire.) using fluoroscopy, visualize the stent to verify full deployment.If incomplete expansion exists within the stent at any point along the lesion, post deployment balloon dilatation (standard pta technique) can be performed.Select an appropriately sized pta balloon catheter and dilate the lesion with conventional technique.The inflation diameter of the pta balloon catheter used for post dilatation should approximate the diameter of the reference vessel.Remove the pta balloon catheter from the patient.¿ neither the phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

Manufacturer Narrative

Film review was received and conclusion was updated: a precise pro carotid 8mm x 40mm self-expanding stent (ses) delivery system was deployed in the presence of a 95% stenosis and was post dilated with a 5mm x 30mm non-cordis percutaneous transluminal angioplasty (pta) balloon catheter; however, images of post dilation revealed stent fracture.The fracture was treated with a 7x15mm balloon expandable coronary stent placed across the stricture segment of the deployed right ica stent.There was good coverage of the fractured area with improvement in the stenosis at the right ica origin.A right carotid artery stenting procedure was being performed in the internal carotid artery (ica) at a carotid bifurcation.The lesion was 30mm in length in a 6.85mm in diameter the common carotid and 3.78mm in diameter in the ica.The lesion was calcified but there was no vessel tortuosity.The precise stent was stored, handled, inspected and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.A 6f non-cordis sheath was used in the procedure.The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.The stent delivery system did not pass through any acute bends.Delivery of the sds to the lesion was ipsilateral.There was no difficulty encountered while advancing/tracking the sds towards the lesion.There was no unusual force used at any time during the procedure.There was no thrombus present proximal to, at, or distal to the lesion site.The lesion was not pre-dilated prior to stent implantation.There was no difficulty or resistance noted while crossing the lesion with the stent.The sds did not have to pass through a previously placed stent.The stent expanded fully with good wall apposition.The device was not returned for analysis.Films were received.Observations: a single cd-rom containing multiple cine files from the procedure is submitted for review.A 4-vessel cerebral arteriogram was initially performed.There is high grade stenosis of the right internal carotid artery at its origin secondary to heavily calcified plaque.This results in greater than 90% stenosis.A tandem calcified plaque just distal to this produces 50% stenosis.The ica is not tortuous.A distal protection device is placed.As per clinical report, the target lesion was not pre dilated.Subsequent images show deployment of an 8 x 40mm precise pro stent extending from the common carotid into the internal carotid artery and spanning both areas of stenosis in the ica.Following post deployment angioplasty there appears to be significant waist on the stent at the ica origin.Subsequent images show slight improvement of this stenosis suggesting that additional angioplasty may have been performed.The distal protection is then removed.Non-contrast images show fracture of the stent at the level of the ica origin.This is minimally displaced.A second stent is placed across the stent fracture.Final images show successful treatment of the stenosis with an appropriate flow lumen.There is good wall apposition.There is no evidence of extravasation, dissection, or distal embolization or spasm.A product history record (phr) review of lot 18018573 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent-ses~ fractured - in patient¿ was not confirmed.Per clinical report, physician review of this case states ¿this complaint involves a patient who had a precise pro carotid stent placed in the right carotid artery to treat two tandem ica lesions.Following post deployment angioplasty, the stent fractured which required a second stent to be placed.Upon initial deployment and before angioplasty the stent is not fractured.The fracture occurred during post deployment balloon dilation.It is most likely that one (or perhaps two) balloon dilations against heavily calcified eccentric plaque with high grade stenosis resulted in the stent fracture.In my practice, our physicians typically balloon dilate the lesion after placement of the distal protection and before stent placement.We almost never perform post deployment balloon dilation of a carotid stent.Post stenting balloon dilation carries high risk for complications including dissection, embolization, vessel rupture and hypotension.In my practice i have never seen stent fracture during initial placement in the carotid artery.Nevertheless, stent fracture is a well-established potential complication found in post procedure surveillance.Some physicians believe that micro fractures formed in the stent during initial placement from adjacent heavily calcified plaque and/or post deployment balloon dilation contribute to subsequent complete fracture of the stent.In this case, perhaps more aggressive post dilation to treat the recalcitrant stenosis resulted in fracture.The treating physician handled the complication correctly and the patient had a good result.This patient may be at risk for subsequent in stent restenosis and careful surveillance should be done at regular intervals.In my opinion, this case does not represent product malfunction but is procedurally related.This is an excellent example of the difficulties that a treating physician can encounter when treating high grade calcified carotid lesions.¿ additionally, per the instructions for use (ifu) ¿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 phr review nor the film analysis suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.No additional information is available and therefore no further reports will be forthcoming.

• Brand Name: 8X40MM PRECISE PRO RX NITINOL STENT SYSTEM
• Type of Device: STENT, CAROTID
• MDR Report Key: 12224674
• MDR Text Key: 263392812
• Report Number: 9616099-2021-04733
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036495
• UDI-Public: 20705032036495
• Combination Product (y/n): N
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: PC0840RXC
• Device Lot Number: 18018573
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• 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
• Treatment: VIATRAC 5X30 PTA AND HERCULINK 7X15MM CORONARY STE.; VIATRAC 5X30 PTA AND HERCULINK 7X15MM CORONARY STE
• Patient Outcome(s): Required Intervention
• Patient Weight: 75