MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION VALVE CONDUIT CONTEGRA; CONDUIT,VALVED,PULMONIC

Model Number PVC222

Device Problems Calcified (1077); Gradient Increase (1270); Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem Hematoma (1884)

Event Date 02/10/2004

Event Type  Injury  

Event Description

Medtronic received information via a journal article in the annals of thoracic surgery regarding a study of 67 patients who were discharged april 1999 to december 2003 after implantation of a contegra conduit.Patient demographics: mean age 16.1 years (range 2 months to 53 years), mean weight 39.7kg (range 4 to 95kg).Conduit size was 14mm (n=2), 16mm (n=7), 18mm (n=12), 20mm (n=13), 22mm (n=33).Mean follow-up of 26.4 months (range 1 to 56 months) revealed the following adverse events related to the device: - twisted conduits (n=2, 22mm devices): the authors indicated that these twisted conduits were due to technical problems at implant, and concluded that they were "correlated with the learning curve in the use of this type of conduit, which is much more soft and pliable than the conventional homograft and therefore less forgiving with regard to potential twisting." patient #1: the conduit was explanted and replaced 16 months post-implant.It was reported that the device was twisted between the v alve and the distal anastomosis, with an internal diameter equal to 50% of the recorded proximal and distal values, corresponding to a peak pressure gradient of 27mmhg and mean gradient of 24mmhg (see fig.2 in the attached article).Patient #2: 1 month post-implant a stent was implanted in the conduit proximal to the valve.The conduit was not explanted.- conduit compression (n=1, 22mm): 3 months post-implant, extrinsic conduit compression, speculated to be due to a hematoma, was treated with a stent implantation between the valve and the distal anastomosis.Electrocardiogram-gated multi-slice computer tomography (ecg-gated msct) indicated a 30% reduction of the internal diameter distal to the conduit valve.The patient had a small calcification (2.3mm diameter) detected in the conduit wall (fig.3).Citation: authors: antonio f.Corno, md, frcs, salah d.Qanadli, md, phd, nicole sekarski, md, simona artemisia, md, michel hurni, md, piergiorgio tozzi, md, and ludwig k.Von segesser, md, facs journal name: annals of thoracic surgery year: 2004 issue #: 78:1382¿8 title of article: bovine valved xenograft in pulmonary position: medium-term follow-up with excellent hemodynamics and freedom from calcification literature reference #: doi:10.1016/j.Athoracsur.2004.02.095.

Manufacturer Narrative

Endocarditis, stenosis/high gradients, calcification, and regurgitation are known adverse events for this device.The sterilization process used by medtronic has an anti-microbial kill on the microorganisms such as staphylococcus and streptococcus species.Also, the sterilization process has an anti-microbial kill for our process which is validated using the worst case bacillus atrophaeus (gram-positive spore forming rods), which is known to be representative of the cleanroom bioburden and our process is validated is effective.As reported, the observed twisted conduits were attributed to technical problems and level of implanter experience.A query of medtronic¿s databases five years did not reveal any other customer complaints regarding this type of observation.A device history records review could not be performed, as the serial numbers were not provided.To date, no additional information has been provided by the article¿s author contact.Based on the limited information received, a true root cause to the clinical observations cannot be determined.

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observations.(b)(4).

Manufacturer Narrative

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

• Brand Name: VALVE CONDUIT CONTEGRA
• Type of Device: CONDUIT,VALVED,PULMONIC
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 east 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: 4258571
• MDR Text Key: 4990442
• Report Number: 2025587-2014-00902
• Device Sequence Number: 1
• Product Code: MWH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: H020003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2014

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: PVC222
• Device Catalogue Number: PVC222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2014
• Initial Date FDA Received: 11/18/2014
• Supplement Dates Manufacturer Received: Not provided; 12/05/2014
• Supplement Dates FDA Received: 12/09/2014; 09/15/2017
• 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): Required Intervention
• Patient Age: 00016 YR
• Patient Weight: 39