MAUDE Adverse Event Report: BALT EXTRUSION SILK VISTA BABY INTRACRANIAL SELF-EXPANDABLE STENT

Model Number SILK_V_2,25X10

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Hemorrhage/Bleeding (1888); Coma (2417); Ruptured Aneurysm (4436)

Event Date 05/19/2022

Event Type  Death  

Manufacturer Narrative

Balt extrusion reference #(b)(4)/ balt usa reference #(b)(4).This unit was used in an expanded access emergency use case (silk vista baby not currently approved for commercial distribution within the united states).The hospital report received for the case mentions the following impression: "successful silk stent device embolization of the anterior cerebral artery ruptured blister aneurysm.There was no further filling of the dome of the aneurysm after embolization." the investigation was performed by legal manufacturer, balt extrusion.Summary as follows: the affected device silk_v_2,25x10 was not returned to balt extrusion for inspection as it was implanted.As a result, we could not proceed to the full analysis of the reported event.This analysis was based on the manufacturing records for this specific batch, the information provided by the healthcare facility (e.G., medical report), a review of the case by an independent physician, and the data issued from our post-marketing surveillance process.The lot history record (lhr) review did not highlight any anomaly which could potentially explain the issue experienced during the procedure.During the manufacturing process, several tests are performed: conformity of stent braiding (absence of damage) is 100% controlled by visual inspection.Proper sliding of the stent through its introducer with distal deployment is 100% controlled.The stent and its pusher are 100% controlled by visual inspection.No similar event is registered to date on this lot number in our database.The incident description mentions a deployment issue of the stent during the procedure: "distal and mid sections were open and fully opposed to vessel wall.Proximal end of stent did not open completely and looked to be jailing the aca".Based on the information gathered, difficulties observed during the procedure could be explained by the patient anatomic specifications (e.G., tortuous vessels).In fact, it has been reported that "multiple wires used throughout the case due to tortuosity and to canalize vessels." and "a slight bend in vessel with mild stenosis could be appreciated in the imaging".The tortuous anatomy of the patient was also observed in the medical imaging.This anatomy specification could prevent the proper deployment of the stent.Indeed, the patient's tortuous anatomy could make the navigation and sliding of the device tougher, which could impact its deployment.As mentioned in the instruction for use (mde046 ind15 §4): "use of the silk vista baby stent is contraindicated in the following cases: "patients with anatomy that does not permit passage or deployment.".Besides, the incident description mentioned that the silk vista baby was deployed but failed to open in the proximal end of it, but no images of the aneurysm of the implant site were available to perform an assessment of the position of the partially deployed stent in relation to the artery.Moreover, according to the incident description, the physician had to choose a contralateral approach via the acoa to deploy the stent.Thus, the configuration of the site and its location seem to be difficult to access and could explain the issue experienced by the user.Finally, the patient's injury does not seem to be related to the silk vista baby used but potentially to the angioplasty performed, which could have caused an overpressure in the artery leading to the rupture of the parent artery.In conclusion, having regard to the absence of the slik vista baby stent, we were not able to fully investigate the case.The quality of the device does not seem to be involved in this incident as the review of the manufacturing records did not reveal any anomaly.The most probable hypothesis remains on the patient anatomy (e.G., tortuous vessels) and/or the configuration of the implant site.

Event Description

It was reported that: "prep: right radial with 071 7f rist catheter, phenom plus and sl10 // right femoral with 7f infinity sheath, phenom plus and phenon 17.Diagnostic angiograms of of right and left ica, mca and aca were performed to get better and more recent views of anatomy to measure vessel diameter, aneurysm neck, vessel length, etc.Since physician did not want to have to jail the mca with svb, and the uncertainty of being able to land the proximal end of the stent without it jailing the mca if deployment was done from right ica, he decided to go contralateral and come to the right side via the left aca vasculature.This way he would have more control landing the distal end of the stent past the aneurysm neck without going into the mca territory.Prior to the procedure we discussed the characteristics of the device with the physician, going over measurements, tip wire lengths, marker bands, devices available, stent dimensions based on device package, the need for a specific 017 microcatheter (017 headway or phenom) to be used, and stent prep and deployment techniques.The physician requested a 2.25x10mm device (lot#00468607, exp 2024-12) which was opened and after prepping it was introduced into a phenom 17 mc from the right femoral access site.Multiple wires used throughout the case due to tortuosity and to canalize vessels (synchro14, aristotle14, hybrid12/14).I believe it was the hybrid wire that was able to cross from left aca to right aca and microcatheter position was obtained and svb was then slowly deployed in a "drop and drag" technique from mca back to the right aca, distal landing zone was secured, stent opened across the aneurysm neck and deployment continued until physician felt he had good coverage and stent was completely released.Distal and mid sections were open and fully opposed to vessel wall proximal end of stent did not open completely and looked to be jailing the aca.A slight bend in vessel with mild stenosis could be appreciated in the imaging.Numerous attempts were made to move push wire to see if stent would open to no avail.The phenom 17 catheter was used to "push" the stent, but it did not move.At this time, the physician decided to go back through the stent from the right ica, which was finally successful after multiple attempts with different wires after about 40minutes of trying.Wires were introduced through stent to the end to see if the stent would open but it did not even though he was able to get the wire very distal on the aca and the phenom17 past the constrained portion of the stent.After about an hour of failing to get end of stent to open, the physician asked for an eclipse2l balloon, which was prepped and introduced into the right ica, but then quickly removed and replaced with a transform sc super compliant occlusion balloon catheter 4mmx7mm (lot#22644195, exp 2022-12-13).Balloon was prepped and introduced into stent over an.014 wire.It was positioned distally and 2 dilatations were performed.A few seconds into 2nd dilatation the balloon was noted to bulge and a ruptured occurred.Emergent measures were undertaken by the physician, and the anesthesiologist in the room.Additionally, neurosurgery was called and plans for an evd placement were started while the aca was being coiled and sacrificed.Patient taken to dyna ct and for evd." update 03jun2022 - additional information received from the issuer: "patient is still alive and in a coma as of (b)(6) 2022" update 14jun2022 - additional infomration received from the issuer: "on (b)(6) 2022, the patient was declared dead at 16:23.".

• Brand Name: SILK VISTA BABY INTRACRANIAL SELF-EXPANDABLE STENT
• Type of Device: SILK VISTA BABY
• Manufacturer (Section D): BALT EXTRUSION; 10 rue de la coix vigneron; montmorency, 95160 ; FR 95160
• Manufacturer Contact: moises colin ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 14777925
• MDR Text Key: 294533598
• Report Number: 3014162263-2022-00019
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SILK_V_2,25X10
• Device Lot Number: 00468607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2022
• 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
• Patient Outcome(s): Hospitalization; Death