MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS CRIMPER; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9100CR26

Device Problem Device Packaging Compromised (2916)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2014

Event Type  malfunction  

Event Description

It was reported that during the inspection of a crimper prior to use, a hole was noted in the crimper packaging.A second crimper was used during the procedure.Reportedly the crimper was stored in the shelf box at the facility.

Manufacturer Narrative

Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Manufacturer Narrative

Due to no product (or photo) returned for evaluation, the complaint of damaged pouch could not be confirmed.However, a capa was initiated by edwards to address a packaging issue that resulted in potential damage to the pouch.Although this particular complaint could not be confirmed, it can be speculated that this complaint is related to the same issue.In 2013, during routine inspection of product in our manufacturing process, edwards learned that damage to the crimper¿s sterile barrier pouch can occur if the crimper, while still inside the pouch, comes in contact with hard surfaces.Edwards lifesciences initiated a class ii product notification in the united states via customer letters sent on march 26, 2013.The notification instructed customers to (1) maintain the crimper device in its unit shelf box until ready for use, and (2) to inspect the pouch for holes and damage prior to use, as instructed in the product instructions for use (ifu) and labeling.The customer was also advised that edwards is developing and qualifying a more robust package that will be less susceptible to handling damage, and this improvement will be implemented within the next few months.Through the capa investigation, the crimper pouch holes could be recreated through contact between the crimper base and other hard surfaces including other crimpers, racks, work tables, and the pass-through window.It was discovered that this crimper models base, by design,was more prone to puncture the pouch than other crimper models.Short term corrective actions were implemented in the manufacturing process: minimize handling of the device once in the pouch prior to placement of the crimper into the shelf box.Elimination of hard surfaces and sharp edges that the pouched crimper may contact prior to placement of the crimper into the shelf box.3) implement a final quality inspection of the pouch just prior to placement of the crimper into the shelf box.Since this time, corrective actions in the form of addition of a foam wrap around the crimper base was implemented to prevent reoccurrence of this failure mode.It should be noted that this crimper was manufactured prior to the initiation of corrective actions.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.

• Brand Name: EDWARDS CRIMPER
• 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: deborah deutsch ; 1 edwards way; irvine, CA 92614 ; 9497564213
• MDR Report Key: 3714343
• MDR Text Key: 4269332
• Report Number: 2015691-2014-00729
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2016
• Device Model Number: 9100CR26
• Device Lot Number: 59459923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2013
• 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