MAUDE Adverse Event Report: VENITI, INC. VICI

Model Number	26930
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No procedure date reported, use first date of the month bsc became aware.
Event or Problem Description
It was reported that a stent partial deployment occurred and additional intervention was required.A 12x60x100 vici self expanding stent was selected for use in a previously implanted re-stenosed stent in the subclavian.During the procedure the physician had ballooned the stenosis and when he pinned the vici system and pulled back, it was noted the stent did not flare open as usual.The distal end of the stent moved despite the proximal end of the stent being deployed and the stent became stuck.In an attempt to fully deploy the stent, the physician attempted to snare the nosecone and discovered that the stent was still attached to the deployment system.The physician then cut through the sheath down to the wire and pulled the nosecone out through the groin, and the rest of the system was removed through the sheath in the arm.A balloon was used to open the constrained stent and it opened.The stent folded back on itself but was visually checked with an ivus catheter and looked acceptable.There were no patient complications reported and the patient seemed to be doing fine.
Event or Problem Description
It was reported that a stent partial deployment occurred and additional intervention was required.A 12x60x100 vici self expanding stent was selected for use in a previously implanted re-stenosed stent in the subclavian.During the procedure the physician had ballooned the stenosis and when he pinned the vici system and pulled back, it was noted the stent did not flare open as usual.The distal end of the stent moved despite the proximal end of the stent being deployed and the stent became stuck.In an attempt to fully deploy the stent, the physician attempted to snare the nosecone and discovered that the stent was still attached to the deployment system.The physician then cut through the sheath down to the wire and pulled the nosecone out through the groin, and the rest of the system was removed through the sheath in the arm.A balloon was used to open the constrained stent and it opened.The stent folded back on itself but was visually checked with an ivus catheter and looked acceptable.There were no patient complications reported and the patient seemed to be doing fine.
Additional Manufacturer Narrative
B3: date of event.The event date was not provided.The first date of the month of the aware date was selected.Device evaluated by mfg: the device was returned.A clean cut was observed through the outer shaft, midshaft, and inner shaft, consistent with reported events from the procedure during which the physician intentionally cut through all shafts using a sharp blade.Minor bends and kinks were observed on the outer shaft, midshaft, and inner shaft distal to the cut location.The assembly was confirmed to have all delivery system components present with no broken or detached pieces aside from the known cut made to the shafts.The device was found to be separated into three (3) pieces with residual biological material (ex.Blood) remaining within the inner lumens of the shafts and hub components.The catheter shafts were reassembled by inserting inner shaft into the id of the midshaft.Minimal resistance was felt during insertion.The outer shaft was confirmed to move freely over the midshaft on both halves of the device (proximal and distal to the cut location) as required for typical stent deployment.No gross abnormalities or defects were noted for the overall assembly in terms of hypotube travel distance or shaft length (inner shaft, midshaft, and outer shaft).The nosecone was visually inspected and confirmed to be intact and securely attached to the distal inner shaft.The adhesive fillet was present and confirmed to be smooth and uniform around the entire circumference.There was no indication that the stent or other delivery system components contacted the adhesive prior to being fully cured.Only minor indentations/gouges were observed on the proximal edge of the nosecone taper.The distal outer shaft was visually inspected under magnification.The ptfe liner was confirmed to be intact and securely affixed to the id around the entire circumference.No adhesive or other foreign material was observed on the inner or outer surfaces aside from residual biological material (ex.Blood).Dents and localized deformations were present on the end of the outer shaft distal to the ro marker band.

• Brand Name: VICI
• Manufacturer (Section D): VENITI, INC.; 4025 clipper court; fremont CA 94538
• MDR Report Key: 9430827
• Report Number: 2134265-2019-15113
• Device Sequence Number: 2687123
• Product Code: QAN
• UDI-Device Identifier: 00852725008096
• UDI-Public: 00852725008096
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P180013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 26930
• Device Catalogue Number: 26930
• Device Lot Number: 0019040017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR