MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CONTEGRA; CONDUIT,VALVED,PULMONIC

Model Number PVC200

Device Problems Calcified (1077); Gradient Increase (1270)

Patient Problems Pulmonary Valve Stenosis (2024); Regurgitation, Valvular (2335)

Event Date 11/27/2015

Event Type  Injury  

Manufacturer Narrative

It was reported by the facility that the device would not be returned or made available for analysis.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.(b)(4).

Event Description

Medtronic received information that one year post implant of this bioprosthetic valved conduit, an echocardiogram showed mild pulmonary stenosis, with a peak gradient of 17 mmhg, and mild-moderate narrowing of the distal conduit, proximal to the branch pulmonary arteries, with a peak gradient of 27 mmhg, mild pulmonary valve regurgitation, and dilated/hypokinetic right ventricular outflow tract (rvot) just proximal to the right ventricle to pulmonary artery (rv-pa) conduit.One year post-implant, the patient was admitted to the hospital for a febrile illness.At this time, a cardiac magnetic resonance imaging (mri) showed inflammation of the valved conduit itself with some surrounding soft tissue swelling.The rvot appeared significantly dilated, thin-walled and paradoxical to the level of this rv-pa conduit, consistent with an aneurysmally dilated rvot status post tetralogy of fallot and pulmonary atresia repair.Mild pulmonary regurgitation was observed.The wall of this valved conduit appeared relatively thickened and irregular with mild to moderate narrowing; mural thrombus could not definitively be excluded, but no obvious vegetation was seen in the conduit, or in the remainder of the heart, and the echocardiogram results appeared stable.Patient subsequently presented with a positive adenovirus and streptococcus pneumoniae bacteremia.A 10 day course of antibiotics was initiated.One year, six months post-implant, the patient presented with a significant increase in rv-pa conduit gradient, dilated and hypokinetic rvot just proximal to rv-pa conduit, moderate-severe narrowing of the distal conduit, mild pulmonary valve regurgitation.Two years, post-implant, the conduit was explanted and upsized, replaced with a 16 mm cryopreserved aortic homograft.Upon explant of this valved conduit, the physician reported that the pulmonary valve was slightly calcified and one of the leaflets appeared degenerated.A portion of this conduit was submitted to microbiology for gram staining and culturing.The microbiology lab reported no organisms were seen five days post-explant.No other adverse patient effects were reported.

Manufacturer Narrative

Conclusion: a review of the device history record showed that this device met all manufacturing specification for product released to distribution.No issues were noted that would have impacted this event.A true root cause to the reported clinical observations is not determined.Based on the above investigation, the endocarditis is unlikely to be attributed to the device and/or manufacturing process.Overall, a true root cause to the reported clinical observations is not determined.However, there is no indication that the reported clinical observations were related to the manufacture of the device.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: CONTEGRA
• Type of Device: CONDUIT,VALVED,PULMONIC
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5367977
• MDR Text Key: 36000098
• Report Number: 2025587-2016-00060
• Device Sequence Number: 1
• Product Code: MWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2016
• Device Model Number: PVC200
• Device Catalogue Number: 200H12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/13/2016
• Initial Date FDA Received: 01/14/2016
• Supplement Dates Manufacturer Received: Not provided; 03/02/2016
• Supplement Dates FDA Received: 03/08/2016; 09/19/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/23/2013
• 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: 00032 MO
• Patient Weight: 11