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

Model Number HC150-12

Device Problems Calcified (1077); Gradient Increase (1270); Obstruction of Flow (2423)

Patient Problems Calcium Deposits/Calcification (1758); Stenosis (2263); Vascular System (Circulation), Impaired (2572)

Event Date 06/03/2018

Event Type  Injury  

Manufacturer Narrative

Citation: murala js et al.Right ventricular outflow tract obstruction: a quest for ideal management.Asian cardiovasc thorac ann.2018 jul;26(6):451-460.Doi: 10.1177/0218492318779963.Epub 2018 jun 3.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 a review of the techniques, conduits used, outcomes, and ongoing and future research aimed at identifying the ideal procedure for right ventricular outflow tract obstruction.The method of how the study data was selected was not disclosed and a publication date range for the studies reviewed was also not provided.The study population included an unknown number of patients (predominant gender, mean age and weight were not provided), an unidentified number of which were implanted with a medtronic contegra valved conduit or a medtronic hancock valved conduit.No serial numbers were provided.Among all patients, it was noted that 5.7% of those who received a xenograft valved dacron conduit experienced a homograft implantation related death at 5 years post-implant.However, multiple manufacturers were noted in the literature; based on the available information, medtronic product did not cause or contribute to these deaths.Among all contegra patients, adverse events included: reintervention resulting from distal conduit stenosis, conduit failure/dysfunction, pseudoaneurysm, excessive intimal peel formation, and thrombus.Among all hancock patients, adverse events included: large pressure gradients (>75 mm hg) with varying calcification requiring intervention, mild to moderate obstruction (gradient 45 mm hg) at the conduit valve ring, and stenosis.Multiple manufacturers were noted in the literature; based on the available information a direct correlation could not be made between medtronic product and the observed 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: 8009609
• MDR Text Key: 125161413
• Report Number: 2025587-2018-02853
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P790007
• 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
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• 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
• Date Manufacturer Received: 10/10/2018
• 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