MAUDE Adverse Event Report: BRIVANT LTD. T/A LAKE REGION MEDICAL ENROUTE,ST,MOD,S,HY,US 95-014

Model Number 901047-01

Device Problem Material Integrity Problem (2978)

Patient Problem Vascular Dissection (3160)

Event Type  malfunction  

Manufacturer Narrative

Complaint investigation underway and will be attached to this report.

Event Description

Silk road medical reported the following event: following uneventful access and insertion of arterial sheath and clamping, the enroute.014 wire was advanced in attempt to cross the lesion which created a dissection.Manipulation of the sheath and wire were attempted in attempt to regain the true lumen but were unsuccessful.Re-manipulation of sheath and introduction of.014 command es wire was attempted and wire advanced but following confirmatory angio was found to be extra-luminal.Wire was re-tracted, sheath was manipulated and re-tracted, wire was re-advanced and found the true lumen and crossed the lesion and placed in the distal ica.With the wire being extra-luminal, a 6mm x 2.5cm viabahn was placed in the proximal ica with an 8mm x 30mm enroute stent extending into the cca.Sheath insertion site angiographically still looked irregular, so the cca was exposed and an approximate 2-3cm dissection was identified.Multiple 6-0 and 7-0 sutures were used to tack the dissection.Cca was proximally re-accessed and cca angiogram performed in multiple views confirming successful cca dissection repair.Patient went for post-procedure ct to evaluate in an axial plane which was negative for residual dissection.Patient was recovered in the icu and awoke with no neuro deficit with a normal neuro exam.

Manufacturer Narrative

Complaint investigation underway and will be attached to this report attachment: [(b)(4) complaintinvestigationform.Pdf].

Event Description

(b)(4) reported the following event: following uneventful access and insertion of arterial sheath and clamping, the enroute.014 wire was advanced in attempt to cross the lesion which created a dissection.Manipulation of the sheath and wire were attempted in attempt to regain the true lumen but were unsuccessful.Re-manipulation of sheath and introduction of.014 command es wire was attempted and wire advanced but following confirmatory angio was found to be extra-luminal.Wire was re-tracted, sheath was manipulated and re-tracted, wire was re-advanced and found the true lumen and crossed the lesion and placed in the distal ica.With the wire being extra-luminal, a 6mm x 2.5cm viabahn was placed in the proximal ica with an 8mm x 30mm enroute stent extending into the cca.Sheath insertion site angiographically still looked irregular, so the cca was exposed and an approximate 2-3cm dissection was identified.Multiple 6-0 and 7-0 sutures were used to tack the dissection.Cca was proximally re-accessed and cca angiogram performed in multiple views confirming successful cca dissection repair.Patient went for post-procedure ct to evaluate in an axial plane which was negative for residual dissection.Patient was recovered in the icu and awoke with no neuro deficit with a normal neuro exam.

• Brand Name: ENROUTE,ST,MOD,S,HY,US 95-014
• Type of Device: ENROUTE,ST,MOD,S,HY,US 95-014
• Manufacturer (Section D): BRIVANT LTD. T/A LAKE REGION MEDICAL; parkmore west business park; galway, ; EI
• MDR Report Key: 8183977
• MDR Text Key: 131377047
• Report Number: 3006010712-2018-00019
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K160643
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 901047-01
• Device Catalogue Number: SR-014-GW
• Device Lot Number: 10917705
• Date Manufacturer Received: 12/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other