MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS CLASSIC¿ ANNULOPLASTY RING

Model Number 4400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 10/17/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned to edwards for evaluation.Attempts to retrieve the device and additional information are in process.The device history record (dhr) review could not be performed as the serial number is unknown.Without additional information the clinical observation cannot be confirmed and cause remains indeterminable.If additional information is received a supplemental mdr will be submitted.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards received information a annuloplasty ring was found to have migrated into the abdominal aorta after two week post implant.As reported, the first attempts to extract the ring was made with endovascular long forceps but it failed and a mini laparotomy was subsequently done to explant the device.

• Brand Name: CARPENTIER-EDWARDS CLASSIC¿ ANNULOPLASTY RING
• Type of Device: ANNULOPLASTY RING
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; ms mle-2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 6623394
• MDR Text Key: 77217220
• Report Number: 2015691-2017-01653
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K912554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/17/2017

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: 4400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2017
• Initial Date FDA Received: 06/08/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 48 YR