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

Model Number HC150-12

Device Problems Gradient Increase (1270); Material Separation (1562); Obstruction of Flow (2423)

Patient Problems Non specific EKG/ECG Changes (1817); Stenosis (2263); Regurgitation, Valvular (2335); Vascular System (Circulation), Impaired (2572)

Event Date 01/28/2002

Event Type  Injury  

Manufacturer Narrative

Citation: dearani ja et al.Late follow-up of 1095 patients undergoing operation for complex congenital heart disease utilizing pulmonary ventricle to pulmonary artery conduits.Ann thorac surg.2003 feb;75(2):399-410; discussion 410-1.Doi: 10.1016/s0003-4975(02)04547-2.Presented at the thirty-eighth annual meeting of the society of thoracic surgeons, fort lauderdale, fl, jan 28¿30, 2002.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 return of the product no definitive conclusion can be made regarding the clinical observations.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a long-term follow up of patients after undergoing surgical placement of a bioprosthetic conduit between the pulmonary ventricle to the pulmonary artery.All data were collected from a single center between april 1964 and july 1992.The study population included 1,095 patients (predominantly male; mean age 9 years), 566 of which were implanted with medtronic hancock valved conduits (no serial numbers provided).Among all patients, 246 deaths occurred: 183 were due to cardiac causes, 38 to non-cardiac causes, and 25 to unknown causes, respectively.Multiple manufacturers were noted in the literature; based on the available information medtronic product was not directly associated with the deaths.Among all patients, adverse events included: reoperation for conduit replacement, elevated gradients, arrhythmias, conduit regurgitation, conduit stenosis or extrinsic compression, conduit obstruction, and anastomotic dehiscence.Multiple manufacturers were noted in the literature; based on the available information medtronic product may have been associated with the 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: 8664614
• MDR Text Key: 146911479
• Report Number: 2025587-2019-01782
• 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: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• 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: 05/09/2019
• 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