MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CONFIDA EXPANDABLE SHEATH; INTRODUCER, CATHETER

Model Number CES122230

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problems Hematoma (1884); Blood Loss (2597); Pseudoaneurysm (2605)

Event Date 02/19/2020

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product was discarded by the customer; therefore, no product analysis can be performed.  conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that prior to the implant of a 29-millimeter (mm) transcatheter bioprosthetic valve, a 12fr pre-dilation was performed.Upon insertion of the confida sheath, high resistance was felt, and the sheath had bunched/buckled at silicone section.The obesity of the patient may have played a role in the buckling of the sheath.The sheath was removed, and the overlapping of the sheath was no longer present.The insertion site was dilated to 16fr and the sheath was reinserted.Buckling of the sheath was noted a second time.Moderate vessel tortuosity and mild vessel calcification were reported.Bleeding was observed at the access site.The cause of bleeding was due to the sheath not properly positioned all the way to the skin.A pseudoaneurysm of the right femoral artery was noted.The pseudoaneurysm was due to poor hemostasis from the insertion sheath.Following the implant of the valve, the dcs was unable to be removed through the sheath.The dcs and the sheath had to be removed at the same time.After the devices were removed a cutdown was required to repair the artery.It was unknown if the cause for the cutdown was due to a high stick or the calcium at the access site.No additional adverse patient effects were reported.

Manufacturer Narrative

Conclusion: the delivery catheter system (dcs) insertion issues and bunching / buckling on removal are deemed to be related to limitations in the product design making it unsuitable for approximately 38.5% of the patient anatomies.Evaluation of these issues has determined that in order to mitigate, a re-design of the device and/or patient exclusion would be required.As such, medtronic has decided to discontinue the manufacture and sale of the confida sheath.A field corrective action, has been opened to remove the remaining unused units from customer inventories.Updated eval code-conclusion to 12.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CONFIDA EXPANDABLE SHEATH
• Type of Device: INTRODUCER, CATHETER
• 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: 10168725
• MDR Text Key: 197753152
• Report Number: 2025587-2020-01957
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CES122230
• Device Catalogue Number: CES122230
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 9612164-05-11-2020-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male