MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2016-04-20 for ARTEGRAFT manufactured by Artegraft, Inc..
[43154957]
Artegraft, inc. Has contacted the lead author for additional information but to date, no response was received. No device evaluation was able to be performed because the devices were not returned and no lot numbers were provided. The complaint issue will continue to be monitored within artegraft, inc. Quality systems, quality assurance trending. Should additional information become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[43154958]
Literature review of an abstract that was presented at the society for clinical vascular surgery march 12-16, 2016 in las vegas, nevada titled "bovine carotid artery grafts have an acceptable patency for hemodialysis access regardless of sex or weight". The data from 133 bovine carotid artery (bca) artegrafts implanted at pennsylvania hospital between jan 2012 to may 2015 was retrospectively reviewed; 9 of the 133 patients developed graft infection requiring graft excision between 1-9 months after implant. The report states that "infection rates in our series appear lower than ptfe infection rates reported in the literature due to its autologous nature. " additional information was requested from the lead author; however, to date, no response was received.
Patient Sequence No: 1, Text Type: D, B5
[113289754]
Artegraft, inc. Reviewed the scientific article to be published from data which was presented in abstract form, presented at the 44 annual symposium of the society for clinical vascular surgery in las vegas nv. March 12-16 2016. The journal article is titled "bovine carotid artery xenografts for hemodialysis access". Published in the journal of vascular surgery, june 2017, volume 65, issue 6, pages 1729-1734. Doi: http://dx. Doi. Org/10. 1016/j. Jvs. 2016. 12. 109. Artegraft identified several discrepancies in the article data for the numbers of patients and grafts in the study as compared to the poster and abstract. The abstract 'results' section states that between jan 2012 to may 2015 '9 of 133 patients developed graft infection requiring graft excision'; the article states that between jan 2012 and dec 2015 '10 of 133 grafts developed infection requiring graft excision between 1 and 9 months after implantation. ' artegraft reached out to one of the authors of the publication. He did not immediately provide the answers; however, he forwarded the questions to the lead author. On tuesday, june 20, 2017 artegraft, inc. Received the following response from the lead author: "in terms of the increased number of total patients, i increased the length of follow up data between the abstracts and the manuscript. I found one more graft infection because we had 6 more months of data. The primary assisted group lists 130 at risk instead of 131 which is listed in all the other tables, that must be a typo. I'm not sure how the editors or i didn't catch that. As to why i have listed 134 patients but only 131 grafts, i did not have had any data at all of follow up for those three patients to put in so they were excluded. I probably should have stated that somewhere in the manuscript. The patency rates are all accurate though for the 131 patients. " the devices were not returned to artegraft, inc. And no lot /batch numbers or specific patient information were provided.
Patient Sequence No: 1, Text Type: N, H10
[113289755]
From the publication of the abstract to the journal article, 6 months more of additional data was made available. Literature review of the journal article to be published in the society for clinical vascular surgery identified 1 additional patient that developed graft infection requiring graft excision between 1-9 months after implant. In total from this study there were 10 of 133 grafts that developed infection. Patient information was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247686-2016-00004 |
| MDR Report Key | 5591240 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2016-04-20 |
| Date of Report | 2017-05-22 |
| Date of Event | 2012-01-01 |
| Date Mfgr Received | 2017-05-22 |
| Date Added to Maude | 2016-04-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CYNTHIA SALTER |
| Manufacturer Street | 206 NORTH CENTER DRIVE |
| Manufacturer City | NORTH BRUNSWICK NJ 089024247 |
| Manufacturer Country | US |
| Manufacturer Postal | 089024247 |
| Manufacturer Phone | 7324228333 |
| Manufacturer G1 | ARTEGRAFT, INC |
| Manufacturer Street | 206 NORTH CENTER DRIVE |
| Manufacturer City | NORTH BRUNSWICK NJ 089024247 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 089024247 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTEGRAFT |
| Generic Name | COLLAGEN VASCULAR GRAFT |
| Product Code | LXA |
| Date Received | 2016-04-20 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTEGRAFT, INC. |
| Manufacturer Address | 206 NORTH CENTER DRIVE NORTH BRUNSWICK NJ 089024247 US 089024247 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-04-20 |