MAUDE Adverse Event Report: INTACT VASCULAR, INC. TACK ENDOVASCULAR SYSTEM (6F, 3.5-6.0MM); SCAFFOLD, DISSECTION REPAIR

Catalog Number 156120061

Device Problem Insufficient Information (3190)

Patient Problem Thrombus (2101)

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to intact vascular at the time of this report and is not expected to be returned.Intact vascular has attempted to contact the reporter of this event for additional information.If additional information is received after this report, a supplemental report will be submitted.

Event Description

The patient underwent endovascular procedure on (b)(6) 2020.Tack endovascular system (6f, 3.5-6.0mm) was used to treat dissections observed.Displacement of the deployed tack implant(s) was observed.During the index procedure on (b)(6) 2020, the physician deployed three tack implants in right superior femoral artery (sfa) and followed post dilatation of the tack implants, displacement of the tack implant(s) was observed by the physician.The physician then proceeded to deploy eluvia des within the sfa and observed additional tack implant(s) displacement.Unsuccessful attempts were made by the physician to snare the displaced tack implants.The physician completed the procedure by performing another post dilatation step.The conclusion of the index procedure, had the tack implant(s) displaced from mid-sfa to p1 region, angiography demonstrated good blood flow.The physician documented required patient follow-up with ultrasound.Patient ultrasound was taken, and the physician decided to re-intervene based on the results of the ultrasound on (b)(6) 2020.The re-intervention included use of jetstream atherectomy followed by prolonged angioplasty near the tack implanted region.The conclusion of the (b)(6) 2020 procedure, had the physician recommending the patient to vascular surgeon for surgical removal of the tack implant(s).Intact vascular representative was made aware of the incident on (b)(6) 2020.Vascular surgeon dr.Baljeet uppal of the banner boswell medical center performed embolectomy and endarterectomy of the right popliteal artery, tibio-peroneal trunk proximal tibial and peroneal artery on (b)(6) 2020 and explanted at least one of the tack implant(s).The surgical intervention concluded with patient receiving successful revascularization of the right lower extremity and patient remained hemodynamically stable throughout.

Manufacturer Narrative

The device has not been returned to intact vascular at the time of this report and is not expected to be returned.Intact vascular has attempted to contact the reporter of this event for additional information.If additional information is received after this report, a supplemental report will be submitted.

Event Description

The patient underwent endovascular procedure on (b)(6) 2020.Tack endovascular system (6f, 3.5-6.0mm) was used to treat dissections observed.Displacement of the deployed tack implant(s) was observed.During the index procedure on (b)(6) 2020, the physician deployed three tack implants in right superior femoral artery (sfa) and followed post dilatation of the tack implants, displacement of the tack implant(s) was observed by the physician.The physician then proceeded to deploy eluvia des within the sfa and observed additional tack implant(s) displacement.Unsuccessful attempts were made by the physician to snare the displaced tack implants.The physician completed the procedure by performing another post dilatation step.The conclusion of the index procedure, had the tack implant(s) displaced from mid-sfa to p1 region, angiography demonstrated good blood flow.The physician documented required patient follow-up with ultrasound.Patient ultrasound was taken, and the physician decided to re-intervene based on the results of the ultrasound on (b)(6) 2020.The re-intervention included use of jetstream atherectomy followed by prolonged angioplasty near the tack implanted region.The conclusion of the (b)(6) 2020 procedure, had the physician recommending the patient to vascular surgeon for surgical removal of the tack implant(s).Intact vascular representative was made aware of the incident on (b)(6) 2020.Vascular surgeon dr.Baljeet uppal of (b)(6) performed embolectomy and endarterectomy of the right popliteal artery, tibio-peroneal trunk proximal tibial and peroneal artery on (b)(6) 2020 and explanted at least one of the tack implant(s).The surgical intervention concluded with patient receiving successful revascularization of the right lower extremity and patient remained hemodynamically stable throughout.

• Brand Name: TACK ENDOVASCULAR SYSTEM (6F, 3.5-6.0MM)
• Type of Device: SCAFFOLD, DISSECTION REPAIR
• Manufacturer (Section D): INTACT VASCULAR, INC.; 1285 drummers lane; suite 200; wayne, pa
• MDR Report Key: 10093192
• MDR Text Key: 194996233
• Report Number: 3012608866-2020-00002
• Device Sequence Number: 1
• Product Code: QCT
• UDI-Device Identifier: 00863328000103
• UDI-Public: 00863328000103
• Combination Product (y/n): N
• PMA/PMN Number: P180034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 156120061
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2020
• Initial Date FDA Received: 05/27/2020
• Supplement Dates Manufacturer Received: 04/28/2020
• Supplement Dates FDA Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR