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

Model Number HC150-12

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

Citation: sachweh js et al.Size matters: longevity of valved rvot conduits is mainly related to the conduit diameter.Thorac cardiovasc surg 2014; 62 - op56.Doi: 10.1055/s-0034-1367133.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 longevity of valved conduits used in right ventricular outflow tract reconstruction.All data were collected between 1997 and 2013.The study population included 119 patients (mean age 9 years; mean weight 29 kg), 50 of which were implanted with a medtronic contegra valved conduit and 36 were implanted with a medtronic hancock valved conduit.No serial numbers were provided.The surgical mortality rate was 1.7% and late mortality rate 2.6% (reported to be not related to conduit failure).Multiple manufacturers were noted in the literature; based on the limited available information, medtronic product did not cause or contribute to these deaths.Among all patients, adverse events included: reoperation and/or intervention (defined as conduit dilatation or valve replacement).Multiple manufacturers were noted in the literature; however, based on the available information, medtronic product may have caused or contributed to these adverse events.No additional adverse patient effects or product performance issues were reported.

• 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 HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8318351
• MDR Text Key: 135498969
• Report Number: 2025587-2019-00531
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P790007
• 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
• Report Date: 02/07/2019

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 Model Number: HC150-12
• Device Catalogue Number: HC150-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2019
• Initial Date FDA Received: 02/07/2019
• 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: 9 YR
• Patient Weight: 29