MAUDE Adverse Event Report: ARTEGRAFT INC. ARTEGRAFT COLLAGEN A-V GRAFT; BOVINE GRAFT

Model Number ION MONORAIL

Device Problems Fracture (1260); Occlusion Within Device (1423)

Patient Problems Bradycardia (1751); Death (1802)

Event Date 07/28/2015

Event Type  Death  

Event Description

My husband was a dialysis patient for 11 years.Never having any significant problem with his one and only access site.His access site clotted off during treatment so he was referred to his vascular doctor.He went to the vascular doctor.They did an ultrasound and no significant problem was detected but he was scheduled for a fistulagram and subsequent angioplasty.He went for the angioplasty and also had a ballooning and a stent placed.We were told there was slight narrowing but blood flowed well.He was discharged home and went to dialysis as scheduled the next day.At that treatment the tech could not feel a thrill or hear a bruit.My husband was sent back to vascular and it was decided they would put a chest wall port to dialyze him.He was scheduled and went for outpatient insertion of catheter.Catheter was placed and vascular discussed repeat angioplasty for the following week.The following week my husband had another angioplasty ballooning and another stent placed.This also was done on the same arm the previous angioplasty was performed and as the original access existed.The surgeon said bloodflow was good and he rerouted the vessels once again.As before when my husband went to dialysis the following day the site had once again clotted off.He saw vascular again and it was decided a bovine graft would be tried.He was scheduled for the graft.It was performed and post surgery the surgeon said it was good blood flow.Again once my husband went to dialysis on his regular day the graft had clotted off.He went back to the vascular doctor who explained it was possible to try and declot the bovine graft.So he was scheduled for that procedure for the following week.On (b)(6) 2015 he went to the operation room after a delay and was finally operated on and in recovery around 2pm.He ended up having some difficulty breathing in the recovery room and i was told he had a chest xray a breathing treatment and given a benadryl.I was finally able to see him around 5:30 and told me he had shortness of breath in the recovery room.He seemed tired and i asked him if he was ok and he told me "i just need to sleep this benadryl off." he got dressed we came home around 6:30pm.He wanted to lay down so he went upstairs laid down.I went up as well just to keep an eye on him.He laid down for about an hour then sat up and said he wanted to watch tv which he did for a short while then laid back down.At 8:45 pm he made this guttural sound rolled onto his back and i knew right away it was not good.I yelled for my son while i started cpr.My son called 911 and then joined me in cpr.Ems arrived and took over.My husband was not able to be resuscitated.I must add my husband was in good health although he was a dialysis patient.He was alert active and very involved with life.Two hours after being discharged from the hospital he died.My concerns are that either the problem stemmed from the bovine graft or the stents placed in his arm.He also had a coronary stent placed in 2013 and there have been reports of stents fracturing and causing issues.Dates of use: (b)(6) 2015.Diagnosis or reason for use: dialysis access.

• Brand Name: ARTEGRAFT COLLAGEN A-V GRAFT
• Type of Device: BOVINE GRAFT
• Manufacturer (Section D): ARTEGRAFT INC.
• MDR Report Key: 5537444
• MDR Text Key: 41618391
• Report Number: MW5061342
• Device Sequence Number: 2
• Product Code: DSY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/28/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: ION MONORAIL
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 57 YR
• Patient Weight: 122