MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING TRI-AD 900SFC26; RING, ANNULOPLASTY

Model Number 900SFC26

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Hypovolemic Shock (1917); Blood Loss (2597)

Event Date 04/05/2018

Event Type  Death  

Manufacturer Narrative

Citation: jung w et al.Early clinical outcomes of tricuspid valve repair with a tri-ad annuloplasty ring in comparison with the outcomes using an mc3 ring.Korean j thorac cardiovasc surg.2018 apr;51(2):92-99.Doi: 10.5090/kjtcs.2018.51.2.92.Epub 2018 apr 5.Earliest date of publish used for event date and death 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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a comparison of the early outcomes in patients who underwent tricuspid valve annuloplasty with a tri-ad ring or an mc3 ring.All data were retrospectively collected from a single center between january 2007 and march 2017.The study population included 229 patients and was predominantly male with a mean age of 59 years.Of those, 36 were implanted with medtronic tri-ad annuloplasty rings.No serial numbers were provided.Among all tri-ad patients, one operative death occurred due to unidentified bleeding and hypovolemic shock.Based on the available information, medtronic product may have been associated with the death.Among all tri-ad patients, adverse events included: reoperation due to bleeding, low cardiac output syndrome, stroke, atrial fibrillation, moderate-severe pulmonary hypertension, mild-moderate-severe tricuspid regurgitation, and moderate-severe left ventricle dysfunction (left ventricular ejection fraction less than 40%).Based on the available information, medtronic product was associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

• Brand Name: RING TRI-AD 900SFC26
• Type of Device: RING, ANNULOPLASTY
• 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: 9856621
• MDR Text Key: 184174299
• Report Number: 2025587-2020-00864
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K093903
• 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: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900SFC26
• Device Catalogue Number: 900SFC26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2020
• 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): Death
• Patient Age: 59 YR