MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS TRANSFEMORAL BALLOON CATHETER; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9350BC23

Device Problems Burst Container or Vessel (1074); Device Operates Differently Than Expected (2913)

Patient Problems Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)

Event Date 12/01/2015

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is ongoing.

Event Description

During a transfemoral tavr procedure, while performing a bav with a 23mmx4cm edwards transcatheter balloon catheter, the balloon ruptured.The physician was unable to remove the balloon from the sheath.When the balloon was eventually removed, it had become separated and balloon material remained in the patient.There also appeared to be some type of separation of the inner and outer portions of the balloon catheter.A portion remained fixed to the wire, while a portion was removed.Essentially resulting in 3 separate pieces to the balloon.The outer catheter, inner catheter gripping the wire, and the balloon tip / balloon material that remained in the patient.The balloon material that remained in the patient was located in the left common iliac and external iliac and was jailed by 3 covered stents.Per additional investigation of this event, the balloon ruptured during inflation.The physician was unable to fully inflate due to heavy, severe, and bulky annular calcification.There were no abnormalities noted for the bav balloon during preparation or sizing of balloon.There was no difficulty noted when inserting the bav through the sheath.During balloon removal the balloon catheter became separated.The inner portion that travels on the wire remained on the wire while the outer position that is gripped by the physician/tech was removed.The outer portion of the balloon catheter was removed.The inner lumen of the balloon catheter became "glued" to the wire.They attempted to snare the wire tip from the opposite side in an effort to remove it, with balloon material still on it, from the opposite groin.This effort failed.The wire was cut, the e-sheath was removed, and a new 14fr cook sheath was inserted.Additional attempts to remove the balloon were made without success.Eventually the wire and inner balloon catheter were removed., the patient was extubated the following day.2 days post-op the patient was reported as doing well.The patient did have multiple perforation in the right common iliac, external iliac, and right common femoral, the opposite side where the balloon material became lodged.The patient received blood transfusions.The physician indicated the ruptured balloon, having "wings", would not re-enter the e-sheath.There appeared to not be any volume in the balloon.There was no damage to esheath.The distal tip of the balloon separated while attempting to remove the bav.

Manufacturer Narrative

The complaint device was not returned to edwards lifesciences for evaluation.Due to the device (or applicable photo/video, relevant to the reported event) not being returned for evaluation, the complaints of ¿balloon ¿ burst,¿ ¿balloon catheter ¿ withdrawal difficulty ¿ through sheath,¿ and ¿distal tip ¿ separated¿ were unable to be confirmed.Without the device returned for evaluation, functional testing and dimensional analysis were unable to be performed.As noted in the results and findings section, the complaint history and manufacturing mitigation analysis did not indicate that a manufacturing non-conformance was the likely cause of the customer complaint.During manufacturing, the bav is 100% leak tested for any leak paths in the balloon inflation lumen.The balloon is molded and inspected, and inspections are in place for visual non-conformances (foreign matter, impurities, deformation and fish eyes), and double wall thickness dimensions.In addition, samples are destructively tested on the balloon component work order and the bav assembly work order for burst pressure.The inspections during manufacturing support that it is unlikely that a manufacturing non-conformance was the cause of the complaint.The preparation manual and ifu procedure indicated that balloon burst is a potential adverse event when the bav is used.The case file also indicates that the patient had bulky leaflet calcification, which likely contributed to the balloon burst.Once the balloon was burst, the shape of the burst balloon likely contributed to withdrawal difficulties through the esheath, which likely resulted in the distal tip and pieces of the balloon separating from the rest of the catheter by means of withdrawal force utilized during retrieval attempts.The case notes state that the minimal lumen diameter of the access vessel was 5.5mm, and the ifu indicates to use caution in vessels with less than 5.5mm mld.Without functional testing and dimensional analysis engineering is unable to determine the root cause of the failure modes ¿balloon ¿ burst,¿ ¿balloon catheter ¿ withdrawal difficulty ¿ through sheath,¿ and ¿distal tip ¿ separated.¿ the ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.Since no manufacturing non-conformances or ifu/training inadequacies were identified corrective or preventative actions are not required.

Manufacturer Narrative

This report have been updated with the correct lot number, expiration and manufacturing dates for the complaint device.A device history record (dhr) review for the bav showed the device met specifications prior to distribution.There were no non-conformances that could have contributed to the complaint.

• Brand Name: EDWARDS TRANSFEMORAL BALLOON CATHETER
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: frances preston ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 5328940
• MDR Text Key: 34428100
• Report Number: 2015691-2015-03572
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2017
• Device Model Number: 9350BC23
• Device Lot Number: 60195279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2015
• Initial Date FDA Received: 12/28/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/04/2016; 02/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2015
• 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: 64 YR