MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2016-05-26 for ARTEGRAFT manufactured by Artegraft, Inc..
[46026491]
Multiple attempts were made to retrieve the manufacturer batch number and details related to the event; however, to date no additional information was provided. No complaint trend was identified related to patient death. 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. Device not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[46026492]
Medwatch report mw5061342 was received. A family member of the patient reported that the patient had expired. The reporter stated that the patient 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. Multiple procedures (ballooning, stent, chest wall port, repeat angioplasty) were performed as a result of numerous clot issues, the patient's vascular surgeon then implanted a "bovine graft" (artegraft, collagen vascular graft). After implant of the artegraft, initial blood flow was reported as "good". After an unknown time period, the patient went for dialysis treatment and the graft "had clotted off". A declot procedure was scheduled the following week. After the procedure, on (b)(6) 2015 approx. 2pm the patient reported difficulty breathing. The patient had a chest x-ray and breathing treatment and was given a benadryl. Patient was discharged from the hospital and approx. 2 hours later the patient expired. The reporter states that the patient "was in good health although he was a dialysis patient. He was alert active and very involved with life. " the reporter further states, "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. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247686-2016-00006 |
| MDR Report Key | 5682638 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2016-05-26 |
| Date of Report | 2016-04-28 |
| Date of Event | 2015-07-28 |
| Date Mfgr Received | 2016-04-28 |
| Date Added to Maude | 2016-05-26 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | 2016-05-26 |
| 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. Death | 2016-05-26 |