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

Model Number 200H14

Device Problems Calcified (1077); Material Erosion (1214); Stretched (1601); Material Split, Cut or Torn (4008)

Patient Problems Corneal Pannus (1447); No Information (3190)

Event Date 04/25/2019

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 2 years 3 months post implant of this 14mm pulmonary valved conduit implanted in a pediatric patient, the conduit was dilated to over 23-24cm and was explanted and replaced with a non-medtronic device.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that the conduit was dilated 23-24mm (not cm).No additional adverse patient effects were reported.Device availability updated in section d10.Device evaluation updated in section h3.Coding updated in section h6.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Upon receipt at medtronic¿s quality laboratory, visual examination revealed that a 5.2 cm section of the conduit was received for analysis.There were blue monofilament sutures on the inflow and outflow aspects.The valved conduit exhibited a reniform appearance.There was a longitudinal incision along one of the commissures and through the belly of one leaflet.The incision appeared to have occurred during explant.The incision was propagated in order to assess the leaflets and inner lumen.The existing leaflets were slightly stiff but flexible.And the two leaflets were in the closed position.There was an abrasion/tear on the wall, adjacent to the leaflet and commissure.Tissue deterioration was noted on the leaflet adjacent to the tear.The existing commissures were intact.Pannus was found on the inflow aspect and lining the segments of the inner lumen extending to the inferior coaptive area between two leaflets.Additionally, pannus was found on the outflow aspect, and lining segments of the inner lumen.Thick off-white pannus was found on the exterior of the conduit.Radiography showed evidence of calcification on outer segments of the conduit.Calcification was not confirmed on the leaflets.Conclusion: the device history review was performed on the device and there were no correlations / issues identified regarding manufacturing.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.The analysis of the device did not reveal any manufacturing anomalies that may have contributed to the events.Pannus and calcification were noted on the conduit however, likely is not the root cause of the reported dilatation.Coding updated in h6 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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
• MDR Report Key: 8662987
• MDR Text Key: 146807160
• Report Number: 2025587-2019-01766
• Device Sequence Number: 1
• Product Code: MWH
• UDI-Device Identifier: 00643169298637
• UDI-Public: 00643169298637
• Combination Product (y/n): N
• PMA/PMN Number: H020003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2019

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: 12/16/2017
• Device Model Number: 200H14
• Device Catalogue Number: 200H14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 06/03/2019
• Supplement Dates Manufacturer Received: 07/02/2019; 08/16/2019
• Supplement Dates FDA Received: 07/09/2019; 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 MO
• Patient Weight: 11