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

Model Number HC100-12

Device Problem Occlusion Within Device (1423)

Patient Problem No Information (3190)

Event Date 12/11/2012

Event Type  Injury  

Event Description

Medtronic received information via a journal article that six patients with a hancock bioprosthetic valved conduit underwent a post-implant balloon dilatation due to conduit stenosis.The patients were included in a retrospective chart review of 38 patients from a single medical facility who received right-ventricle-to-pulmonary-artery (rv-to-pa) valved conduits over a 127-month period.The article compared the results of a specific non-medtronic manufacturer¿s device with five different types or models of devices.Patient information was de-identified as part of the study, and the information of the five device types/models was aggregated and no detailed information regarding the medtronic devices/patient issues/outcomes could be determined from the article¿s content.The article did note that there was a 31.6% success rate with the balloon dilatations for the five-device group.The article also noted that some patients whose balloon dilatations were not successful did not undergo reoperation, and that some patients whose balloon dilatations were successful underwent reoperation for other factors.No significant complications associated with the balloon dilation procedures were reported.The media age of the patient population in the study was seven years (range: 26 months to 32 years) and the median weight was 21.3 kg (range: 12.5-101.8 kg).

Manufacturer Narrative

An attempt to contact the article¿s lead/corresponding author via the hospital's pediatric department was unsuccessful.Additional efforts are being made to obtain additional information.Without device- or patient-identifying information, it could not be determined if reports have previously been received on any of the six patients in this study article.(b)(4).Percutaneous balloon dilation of carpentier-edwards porcine-valved right ventricle-to-pulmonary artery conduits authors: amanda c.Hall, daniel e.Miga, glenn t.Leonard, hongyue wang, rae-ellen kavey, george m.Alfieris published: december 11, 2012 pediatric cardiology (2013) 34:978¿983 doi 10.1007/s00246-012-0591-2.

Manufacturer Narrative

The reported information did not indicate a potential manufacturing issue.From the available information, a conclusive cause for the clinical observation cannot be determined.

Manufacturer Narrative

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
• 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: 4206216
• MDR Text Key: 15363904
• Report Number: 2025587-2014-00806
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,health professional,lit
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HC100-12
• Device Catalogue Number: HC100-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2014
• Was Device Evaluated by Manufacturer?: No
• 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: 00007 YR
• Patient Weight: 21