MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PERIVUE; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number PVM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Occlusion (1984)

Event Date 04/16/2013

Event Type  Injury  

Event Description

" coronary compression in transapical transcatheter aortic valve procedure", published ann thorac surg 2014; 98: 343, authors: javier gualis,carlos cuellas, felipe fernandez-vazquez, armandoperez, carlosmartín, josemanuelmartínez-comendador, rodrigo estevez-loureiro and mario castano.During transapical approach using a perivue 7.5 cm, sudden ventricular fibrillation occurred due to coronary compression.The patient presented severe thoracic deformity, after resuscitation the valve was deployed without problems.The angiography showed new-onset severe stenosis of the mid segment of the left anterior descending (lad) and the first and second diagonal branches.These three stenoses formed a straight line with no correlation with the previously observed atheromatous disease, suggesting external compression by the soft tissue retractor ring.New drug-eluting stent was implanted successfully in the mid-lad.The postprocedural course was uneventful, and the patient was discharged on the 5th day.

Manufacturer Narrative

" coronary compression in transapical transcatheter aortic valve procedure", published ann thorac surg 2014; 98: 343, authors: javier gualis,carlos cuellas, felipe fernandez-vazquez, armandoperez, carlosmartín, josemanuelmartínez-comendador, rodrigo estevez-loureiro and mario castano.The device was not retained by the hospital for evaluation.Attempts to obtain additional information were unsuccessful.The purpose of the soft tissue retractor is to allow visualization of intra-thoracic structures and provide entry into the thoracic cavity during cardiac surgical procedures.The soft tissue retractor is designed to be inserted into an intercostal incision and retract tissue to form a port.Per report, the device performed the intended function.Per the instructions for use, each physician must determine the appropriate use of this device for each patient based on medical training, experience, the type of procedure employed, and the benefits and risks associated with device use.Comprehensive imaging of the patient¿s ¿severe thoracic deformity¿ was not provided so the alleged relationship of the soft tissue retractor and the new-onset severe stenosis of the mid segment of the left anterior descending artery cannot be confirmed.With out the return of the device or additional information, no definitive conclusions could be drawn regarding the clinical observation.If additional information is obtained, the file wil be updated and a supplemental report will be filed.

Manufacturer Narrative

The article and follow-up with the author suggested that the external compression from the soft tissue retractor combined with the patient¿s multiple preexisting anatomical conditions may have caused new onset severe coronary stenoses.Product risk assessment and labeling review were performed to assess patient risk and labeling content.The decision was made to initiate a labeling update to guide against this rare and unlikely potential adverse event.

Manufacturer Narrative

The customer's thorax is reported as having a great deformity and adherences in the pleuropericardium.These, associated with the use of the device, are reported by the customer as being responsible for the coronary compression.The device was difficult to place due to the thoracic deformity in the patient.The event date was (b)(6) 2013.No additional instruments were used to retract tissues.

• Brand Name: PERIVUE
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 12050 lone peak parkway; draper UT 84020
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 12050 lone peak parkway; draper UT 84020
• Manufacturer Contact: walt wiegand ; 12050 lone peak parkway; draper, UT 84020 ; 8015655200
• MDR Report Key: 4103296
• MDR Text Key: 16775979
• Report Number: 3008500478-2014-00121
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: E142854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2014

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: PVM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2014
• Initial Date FDA Received: 09/19/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/28/2014; 11/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 78 YR