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

Model Number HANCOCKII

Device Problem Fracture (1260)

Patient Problems Endocarditis (1834); Pulmonary Valve Stenosis (2024)

Event Date 05/21/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Title: four-year cardiac magnetic resonance (cmr) follow-up of patients treated with percutaneous pulmonary valve stent implantation citation: eur radiol (2015) 25:3606¿3613 authors: francesco secchi <(>&<)> elda chiara resta <(>&<)> paola maria cannaò <(>&<)> silvia tresoldi <(>&<)> gianfranco butera <(>&<)> mario carminati <(>&<)> francesco sardanelli.No unique device identifier (serial/lot) numbers were provided; without this information it cannot be determined whether this event has been previously reported.

Event Description

Medtronic received information via literature review that a retrospective study was performed to evaluate follow-up data using cardiac magnetic resonance to predict stent fracture and re-stenosis in pulmonary bioprosthetic valves.The study population included 40 patients (predominantly male; mean age 21 +/- 8 years), all of which were implanted with a medtronic transcatheter pulmonary bioprosthetic valve (serial numbers not provided).One patient was implanted with a medtronic surgical bioprosthetic valve (serial numbers not provided).Across all patients 2 incidents of stent fracture occurred.These incidents were most likely due to suboptimal positioning between the stent and the patient's outflow tract.The valves were surgically replaced with conduit.Another adverse event was one incident of endocarditis with stenosis which was treated with implant of a second transcatheter pulmonary valve.It was noted that the endocarditis was most likely the cause of the stenosis.No additional adverse patient effects were reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

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

• Brand Name: VALVE HANCOCK II
• 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: 5312697
• MDR Text Key: 33936557
• Report Number: 2025587-2015-01348
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P980043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2016

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: No Information
• Device Model Number: HANCOCKII
• Device Catalogue Number: HANCOCKII
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2015
• Initial Date FDA Received: 12/19/2015
• Supplement Dates Manufacturer Received: Not provided; 02/09/2016
• Supplement Dates FDA Received: 02/09/2016; 09/19/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 00021 YR