MAUDE Adverse Event Report: ARTEGRAFT, INC ARTEGRAFT; COLLAGEN VASCULAR GRAFT

Model Number AG636

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems Hematoma (1884); Post Operative Wound Infection (2446)

Event Date 01/04/2018

Event Type  Injury  

Manufacturer Narrative

Device 1 of 2; refer to mdr-2247686-2018-00003 for device 2 of 2.The two artegraft (collagen vascular grafts) were not returned to artegraft, inc.For evaluation as they remain implanted.A review of the production batch record was performed; no anomalies were identified.All grafts released from product batch 16j213 passed all of the requirements including pressure testing and sterility testing prior to final release to finished goods.In follow-up conversations between the distributor representative and the surgeons' staff at (b)(6) hospital, it was stated that the tamper evident seal was in place on the box , the shrink wrap was present on the tube prior to use, and the graft was prepared per the ifu prior to use.Artegraft, inc.Mailed a certified letter to (b)(6) hospital requesting additional information related to the events.To date, no additional information was provided.Artegraft, inc.Chief medical officer (qualification: m.D., f.A.C.S.) reviewed the case details and stated that "in the event that a wound infection occurs in the area of the artegraft, increased surveillance must be undertaken.Graft is collagen.Collagen may break down in the presence of pseudomonas, mrsa, e.Coli." artegraft, inc.Ifu dosage and administration section provides instructions for aseptically removing the artegraft from its container.Additionally, the adverse reaction section states "disruption of anastomoses, especially in the presence of infection, has been observed and, in a few cases, transient low grade fever, the etiology, of which has not been obvious, has been experienced." no confirmed complaint trend was identified related to the issue.All product quality and clinical issues will continue to be monitored within artegraft, inc.Quality systems, quality assurance trending.

Event Description

Artegraft, inc.Received an email from an approved distributor representative on behalf of a vascular surgeon ((b)(6)) stating that he recently had 2 patients that acquired infections roughly 2 weeks post-op artegraft (collagen vascular graft) implant for peripheral use.This file will capture patient 1 of 2.On (b)(6) 2017 the patient had femorodistal bypass surgery with two 5 mm artegrafts.The bypass "went down" and the patient ended up in another facility before coming back to dr.Weiss.When the patient presented to him roughly 2 weeks post-op she had pseudomonas.The surgeon mentioned that the graft "dissolved" in a portion where it was infected and had a "big hole" in it.The patient reportedly expired and it was stated that it was "not due to the artegraft".

Event Description

Additional medical notes were provided related to this event.Following the implant of the 2 artegrafts, the patient was released to a nursing facility on (b)(6) 2018.Treatment for severe peripheral vascular disease with occlusions causing nonhealing ulcerations of toes 1 through 4 on the left.On (b)(6) 2017examination, left lower extremity had diffuse swelling.The patient is known to have dry gangrene over the distal tips of toes 1 through 4, as well as redness pitting edema of her foot and calf.The patient's surgical site appeared to have a 1 to 2 cm opening.It was not actively bleeding or draining.There were steri-stips in place.Tenderness was along the entirety of her calf.Imaging identified hematoma of the left proximal calf.The patient presented to be weak and dehydrated.On (b)(6) 2017 procedures included exploration for post-operative hemorrhage, removal of distal portion of possibly infected graft, left popliteal graft to peroneal artery interposition graft.There was a moderately sized hematoma identified.An overlying clot on the distal aspect of the bovine autograft.This was inspected and it appeared to be a segment of weakened artery ~2cm from the distal anastomosis.A separate piece of bovine autograft was brought into the field and used to bridge the distance needed.Flow was restored and there were good signals throughout the graft and foot.While being transferred to the pacu bed the patient began to decompensate.~40 min of cardiopulmonary resuscitation using acls protocol.Tee showed hypokinesis of her lateral wall.12-lead ekg demonstrated myocardial ischemia which was thought to be the reason for decompensation.Dr.Of cardiology evaluated the patient and stated that he felt that the patient was a poor surgical candidate.The patient was stabilized and transferred to the icu.Multiple pressors and bicarbonate for acidosis were given.After 20 min of being in the icu, the patient coded again with vfib arrest.Blood pressure and pulse were regained.The patient coded a third time for about 20 min and was unable to be resuscitated on (b)(6) 2017 at 2026.

Manufacturer Narrative

Follow-up report 1 (see also mdr 224768602018-00003 for the second graft implanted in the same patient at the same time).Additional patient information was provided for the description of the event and relevant history.Additional patient code was added for hematoma.

• Brand Name: ARTEGRAFT
• Type of Device: COLLAGEN VASCULAR GRAFT
• Manufacturer (Section D): ARTEGRAFT, INC; 206 north center drive; north brunswick NJ 08902 4247
• MDR Report Key: 7247260
• MDR Text Key: 99198418
• Report Number: 2247686-2018-00002
• Device Sequence Number: 1
• Product Code: LXA
• UDI-Device Identifier: 00316837000237
• UDI-Public: (01)00316837000237(17)190930(10)16J213-028
• Combination Product (y/n): N
• PMA/PMN Number: N16837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2019
• Device Model Number: AG636
• Device Catalogue Number: AG636
• Device Lot Number: 16J213-028
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR