MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION STRUCTURAL HEART PRODUCT

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Hematoma (1884)

Event Date 10/01/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Title: surgical pulmonary valve replacement: a benchmark for outcomes comparisons citation: j thorac cardiovasc surg 2014;148:1450-3 authors: e.Dean mckenzie, md, muhammad s.Khan, md, thomas w.Dietzman, bs, et al.No unique device identifier (serial/lot) numbers were provided; without this information it cannot be determined whether this event has been previously reported.(b)(4).

Event Description

Medtronic received information via literature review that a retrospective study (july 1995 to december 2010) was performed to evaluate outcomes of pulmonary valve/conduit replacement (pvr) at a large pediatric hospital to provide contemporary benchmark data for comparison with developing technologies.The study population included 148 patients (predominantly male, median age of 15.9 years, median weight 55.3 gk), 52 of which were implanted with a medtronic bioprosthesis (three product families, serial numbers not provided).Multiple patients and multiple manufacturers were noted in the article, however, a one-to-one correlation could not be made between events and product.Among all patients two deaths occurred on follow-up after 2 years post-implant (causes of death were secondary to severe cardiac dysfunction and a respiratory tract infection leading to respiratory failure); neither death was attributed to medtronic product.One noted adverse event included an intervention secondary to mediastinal hematoma in which no active bleeding was identified.Additionally, other interventions occurred, noted as freedom from pulmonary valve re-intervention at 1, 3, and 5 years was 99%, 99%, and 94% respectively, however no other details were provided.No additional adverse patient effects were reported.

Manufacturer Narrative

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

• Brand Name: STRUCTURAL HEART PRODUCT
• 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: 5292002
• MDR Text Key: 33348930
• Report Number: 2025587-2015-01318
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/12/2015

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 Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/12/2015
• Supplement Dates Manufacturer Received: 11/12/2015
• Supplement Dates FDA Received: 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00015 YR
• Patient Weight: 55