MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLSTENT¿ RP ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number M001711300

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2015

Event Type  malfunction  

Event Description

It was reported that the stent was longer than labeled.The target lesion being treated was located in the biliary tract.An 8x80x75/ 6f unistep plus wallstent¿ rp endoprosthesis stent was advanced to treat the lesion.However, when the physician started deploying the stent just before the stent was completely deployed, the length of the deployed stent appeared longer than the length of the lesion.The device was removed and the procedure was completed with a different device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Age at time of event: more than 80 years old.(b)(4).

Manufacturer Narrative

Device evaluated by mfr.: the device was received at the complaint investigation site with the stent fully mounted onto the delivery system.The returned device was received with the stent fully mounted onto the delivery system and was reconstrained prior to return.During analysis, the ro markerbands were positioned correctly indicating that the stent was the correct size.A visual and tactile examination found no kinks or damage along the shaft of the device.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause has been determined to be user preference issue as the product meets specification however the user is dissatisfied with the function, performance, or appearance of the product.(b)(4).

Event Description

It was reported that the stent was longer than labeled.The target lesion being treated was located in the biliary tract.An 8x80x75/ 6f unistep plus wallstent rp endoprosthesis stent was advanced to treat the lesion.However, when the physician started deploying the stent just before the stent was completely deployed, the length of the deployed stent appeared longer than the length of the lesion.The device was removed and the procedure was completed with a different device.No patient complications were reported and the patient's status was stable.

• Brand Name: WALLSTENT¿ RP ENDOPROSTHESIS
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4859745
• MDR Text Key: 5845188
• Report Number: 2134265-2015-03739
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K992510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor,company represent
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2015
• Device Model Number: M001711300
• Device Catalogue Number: 71-130
• Device Lot Number: 0016432437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2013
• 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