MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE; HEART-VALVE, MECHANICAL

Model Number 25AHPJ-505

Device Problems Obstruction of Flow (2423); Device Operates Differently Than Expected (2913)

Patient Problems Dyspnea (1816); Fatigue (1849); Pericardial Effusion (3271)

Event Date 06/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2013, a 25mm masters series was implanted in the aortic position.Per report, a pericardial effusion requiring drainage occurred.On (b)(6) 2016, the patient underwent heart catheterization following reports of dyspnea and fatigue and it was reported that one of the leaflets was not functioning properly.An echocardiogram and tee revealed a median gradient of 25mmhg and fluoroscopy revealed one of the leaflets was ¿fluttering.¿ on (b)(6) 2016, the valve was explanted.Intraoperatively, a moderate amount of subvalvular thrombus and a fibrous stenotic ring of tissue were found and were suspected to be the cause of the obstructed leaflet.A 23mm edwards magna bovine tissue valve was implanted.The patient was discharged in stable condition on (b)(6) 2016.

Manufacturer Narrative

(b)(4).The results of this investigation concluded both leaflets were intact, and were able to fully open and close with no resistance occurring.The bottom rim of the orifice contained three chips.It is unknown how or when the damage occurred.There was no evidence of material defect in the carbon coating that may have caused or contributed to the chipped orifice.Rather, the damage to the orifice may have been caused by some external force applied to the orifice, which overstressed the carbon material and resulted in the damage.There were areas of organizing fibrin and fungal hyphae within the sewing cuff.Special stains were positive for fungal structures.A review of the device history record showed the device met specifications prior to leaving sjm manufacturing facilities.There was no evidence found to suggest there was an intrinsic defect in the valve, as supported by the review of the device history record and by the analysis performed.The cause of the reported event remains unknown.

• Brand Name: SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5910568
• MDR Text Key: 53375102
• Report Number: 2648612-2016-00085
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/18/2018
• Device Model Number: 25AHPJ-505
• Device Catalogue Number: 25AHPJ-505
• Device Lot Number: 3996398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2013
• 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): Required Intervention
• Patient Age: 50 YR