MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-11-02 for ARTEGRAFT manufactured by Artegraft, Inc.
[90906664]
Multiple requests were made to the initial reporter (distributor) and the implanting surgeon for additional information; however, no additional information was provided. Product code, lot number, date of implant, exact date of the event, patient identifier and information were not provided. A review of the production batch records was not able to be completed as the product lot number was not provided. (b)(4). Scientific advisor (qualification: m. D. , f. A. C. S. ) reviewed the case details but was not able to determine possible root cause without additional information. The initial report states that the surgeon was able to successfully patch the graft. No confirmed complaint trend was identified related to hyperplasia. All product quality and clinical issues will continue to be monitored within (b)(4) 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
[90906665]
(b)(4) approved distributor reported the issue on behalf of dr. (b)(6) at (b)(6) hospital). Dr. (b)(6) had recently implanted a primary collagen vascular graft ((b)(4)) as a lower arm loop in a hypotensive african-american male. The patient developed hyperplasia at the venous anastomosis. The surgeon was able to successfully patch the graft. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247686-2017-00011 |
| MDR Report Key | 6996917 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-11-02 |
| Date of Report | 2017-11-02 |
| Date of Event | 2017-10-06 |
| Date Mfgr Received | 2017-10-06 |
| Date Added to Maude | 2017-11-02 |
| 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 | MS. 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 | 2017-11-02 |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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 | 2017-11-02 |