MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HANCOCK; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number HC150-12

Device Problems Obstruction of Flow (2423); Material Split, Cut or Torn (4008)

Patient Problems Pulmonary Regurgitation (2023); Stenosis (2263)

Event Date 08/29/2017

Event Type  Injury  

Manufacturer Narrative

Citation: whiteside w et al.Acute and midterm outcomes of transcatheter pulmonary valve replacement for treatment of dysfunctional left ventricular outflow tract conduits in patients with aortopulmonary transposition and a systemic right ventricle.Circ cardiovasc interv.2017 sep;10(9).Pii: e004730.Doi: 10.1161/circinterventions.116.004730.Epub 2017 aug 29.Earliest date of publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information, it could not be determined whether these observations have been previously reported.Without the return of the product, no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding the viability of transcatheter pulmonary valve replacement (tpvr) for treating patients with a dysfunctional left ventricular outflow tract conduit and the subsequent procedural and mid-term outcomes.All data were collected from 10 centers between december 2008 and august 2015.The study population included 27 patients (predominantly male; mean age 31 years; mean weight 74 kg), 23 of which were implanted with a medtronic melody transcatheter pulmonary valve and 1 was previously implanted with a 25 mm hancock conduit (no serial numbers provided).It was noted that 18, 20, and 22 mm melody valve sizes were used.Among all patients, 2 deaths occurred.Based on the available information, medtronic product was not directly associated with the death(s).For the hancock patient, adverse events included: conduit stenosis, insufficiency, or combination of stenosis/insufficiency requiring transcatheter pulmonary valve replacement and contained conduit tear during conduit angioplasty requiring covered stent placement followed by melody valve implant.Based on the available information, medtronic product was directly associated with the adverse event(s).Among all melody patients, adverse events included: re-dilation of the valve due to mild residual left ventricular outflow tract obstruction (1 case), cardiac transplantation post-tpvr due to symptomatic cardiac dysfunction (1 case), endocarditis (2 cases; occurring at 0.6- and 2.7-years post implant respectively), conduit and tricuspid valve replacement post-tpvr (1 case), hemodynamic instability requiring vasoactive medications (1 case), pulmonary hemorrhage treated with protamine (1 case), mild pulmonary insufficiency (1 case), moderate pulmonary insufficiency (1 case), and new on-set greater than or equal to moderate tricuspid regurgitation and right ventricle dysfunction post-tpvr (9 cases).Based on the available information, medtronic product may have been associated with these adverse event(s).No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Additional information received from the physician/author stated that medtronic product did not cause or contribute to the observed adverse events.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.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: HANCOCK
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8441894
• MDR Text Key: 139533257
• Report Number: 2025587-2019-00999
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P790007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HC150-12
• Device Catalogue Number: HC150-12
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Weight: 74