MAUDE Adverse Event Report: HEART VALVES SANTA ANA MELODY TRANSCATHETER PULMONARY VALVE; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number PB10

Device Problems Gradient Increase (1270); Occlusion Within Device (1423)

Patient Problems Dyspnea (1816); Stenosis (2263)

Event Date 04/01/2015

Event Type  Injury  

Event Description

Medtronic received information that 42 days following the implant of this transcatheter bioprosthetic valve, the patient presented with a 30mmhg mean gradient during moderate exercise with shortness of breath.Postinterventional course showed the valve had stenosis.At 57 days post-implant, the patient had a balloon catheterization procedure done to successfully dilate the valve up to 22mm.The device remains implanted with no further adverse patient effects reported.

Manufacturer Narrative

Event aware date was updated to (b)(6) 2015.

Manufacturer Narrative

Correction: the date of this report and date manufacturer received should have been (b)(6) 2015 on the initial medwatch report.

Manufacturer Narrative

Patient initials are not available for this clinical study.The device remains implanted, therefore no product analysis can be performed.Without return of the product, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

Medtronic received information that 42 days following the implant of this transcatheter bioprosthetic valve (originally implanted inside a stenotic (35 mmhg) and regurgitant non-medtronic ptfe conduit), the patient presented with a 30mmhg mean gradient during moderate exercise with shortness of breath.Post-interventional course showed stenosis was present.At 57 days post-implant, the patient had a balloon catheterization procedure done to successfully dilate the valve up to 22mm, which reportedly resolved the issue.The device remains implanted with no further adverse patient effects were reported.

Manufacturer Narrative

The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.

Manufacturer Narrative

Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.There is no indication that the reported high gradient leading to intervention was attributed to the transcatheter pulmonary bioprosthetic valve (tpbv) design.The physician classified this event as an unexpected residual stenosis.The physician noted that there was no allegation with the tpbv or how it was functioning.The product is performing acceptably and as expected with no noted safety issues or further actions required.Based on the information gathered, there is no indication of product quality issue with this tpbv.The patient's health status likely contributed to the events.Stenosis and regurgitation are known potential adverse events.

Manufacturer Narrative

Medtronic received additional information that the implant of this transcatheter pulmonary bioprosthetic valve into a non-medtronic conduit was successful with no complications.It was reported that 2 months post implant the patient showed symptoms of dyspnea well doing physical activity/exercise.The patient was noted to have not exercised at all before their intervention took place.An echocardiogram showed the patient had a gradient over 60mmhg at stress level, whereas no gradient increase was noted at the time of rest.The physician had noted that their was no allegation with the transcatheter pulmonary bioprosthetic valve or how it was functioning.The physician stated the dilatation was performed on the previous non-medtronic conduit with a balloon up to 22mm.With the dilatation of the previous non-medtronic conduit the gradient was nearly eliminated.This transcatheter pulmonary bioprosthetic valve remains implanted, functioning as intended.

Manufacturer Narrative

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

• Brand Name: MELODY TRANSCATHETER PULMONARY VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): HEART VALVES SANTA ANA; 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: 4840822
• MDR Text Key: 5910921
• Report Number: 2025587-2015-00649
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 06/09/2016
• Device Model Number: PB10
• Device Catalogue Number: PB1016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/24/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 00015 YR
• Patient Weight: 53