MAUDE Adverse Event Report: HANCOCK JAFFE LABORATORIES PROCOL VASCULAR BIOPROSTHESIS; VASCULAR GRAFT

Model Number HJL016-40-N

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Unspecified Infection (1930); Swelling (2091); Thrombus (2101); Discharge (2225); Discomfort (2330)

Event Date 06/24/2015

Event Type  Injury  

Event Description

Approximately 9 months postoperative a male pt with a procol vascular bioprosthesis implanted for av-access in the left upper arm presented with swelling and tenderness overlying the thrombosed bioprosthesis.The pt was admitted to the hospital on (b)(6) 2015, infection was assumed and antibiotics were administered.On (b)(6) 2015 the graft was explanted, an abscess was drained and wound debridement was performed.The pt was discharged from the hospital on (b)(6) 2015.Laboratory and pathology testing did not confirm a microbial presence consistent with infection from specimens collected from the wound or the excised graft material.The pathologist prepared a final diagnosis of acute and chronic inflammation of the graft.

Manufacturer Narrative

The final diagnosis by the hospital pathologist was acute and chronic inflammation of the graft.The infection suspected initially was not confirmed.The explanted material and/or the complete pathology report were not made available for review.A cause for the incident was not determined although a pt response to the device is possible.The device ifu does include pt sensitivity to the device materials as a potential adverse event although a reaction to the device has not been reported prior to this incident.

• Brand Name: PROCOL VASCULAR BIOPROSTHESIS
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): HANCOCK JAFFE LABORATORIES; 70 doppler; irvine CA 92618
• Manufacturer (Section G): HANCOCK JAFFE LABORATORIES; 70 doppler; irvine CA 92618
• Manufacturer Contact: sue montoya ; 70 doppler; irvine, CA 92618 ; 9492612900
• MDR Report Key: 4934578
• MDR Text Key: 6055845
• Report Number: 3008142729-2015-00001
• Device Sequence Number: 1
• Product Code: LXA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 03/09/2019
• Device Model Number: HJL016-40-N
• Device Catalogue Number: HJL016-40-N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 20 YR