MAUDE Adverse Event Report: CORDIS CORPORATION FLEXSTENT VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENTS (FGE)

Model Number SF05080MV

Device Problems Material Frayed (1262); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2014

Event Type  malfunction  

Event Description

After physicians introduced the smartflex catheter shaft tip into the patient, he started to feel some unusual friction.He decided to remove the product and realized that the tip was rounded, but was similar to an open umbrella (not wide open).The product was changed and the procedure finishes successfully.

Manufacturer Narrative

(b)(6).Additional information is pending and will be submitted within 30 days upon receipt.The reporter's name is listed in the report with an email address.Additional details of the address of the reporter are not available and the address listed is that of (b)(6).

Manufacturer Narrative

After the physician introduced the smartflex catheter into the patient, he started to feel some unusual friction.He decided to remove the product and realized that the tip was rounded and resembled an open umbrella (not wide open).The product was changed and the procedure was finished successfully.The stent and delivery system lots were manufactured in accordance with the traveler guidelines.All the required inspections and tests were performed to the specifications provided by the customer and bmt quality system.The subassembly systems provided to flexstent for finished good lot 1401602 were in compliance and therefore, bmt concludes no corrective /preventative actions are required.With the information available and without return of the product for analysis or films of the event it is not possible to draw a clinical conclusion between the device and the reported event.However, vessel characteristics and procedural factors may have contributed to the reported event.

• Brand Name: FLEXSTENT VASCULAR SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS (FGE)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; 6500 paseo padre pkwy; fremont, CA 94555 ; 7863133880
• MDR Report Key: 4251013
• MDR Text Key: 5049650
• Report Number: 3008443827-2014-50010
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K130981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2016
• Device Model Number: SF05080MV
• Device Catalogue Number: SF05080MV
• Device Lot Number: 1401602
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2014
• Initial Date FDA Received: 11/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1