MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT RP ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number 26265

Device Problems Retraction Problem (1536); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2019

Event Type  malfunction  

Manufacturer Narrative

The device was received with the stent fully deployed.The device was received with the stent fully deployed from the device the device.It is not known when deployment occurred.The deployed stent was not returned for analysis.A visual and microscopic examination identified no damage to the stent cups or stent holder that could have contributed to the complaint incident.A visual and tactile examination found no damage or issues to the delivery system that could potentially have contributed to the complaint incident.No other issues were identified during the product analysis.

Event Description

It was reported that stent partial deployment occurred and the device was removed without reconstraining.The 50-60% stenosed target lesion was located in the mildly tortuous and non-calcified transhepatic biliary.A 8x60x75//6f wallstent rp endoprosthesis was advanced for treatment.However, after the stent sheath reached the target position, the stent could not fully deploy.The stent was not fully reconstrained back into the catheter.The device was simply pulled back and removed.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.

• Brand Name: WALLSTENT RP ENDOPROSTHESIS
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8971200
• MDR Text Key: 156794483
• Report Number: 2134265-2019-10796
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729406396
• UDI-Public: 08714729406396
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K152842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2021
• Device Model Number: 26265
• Device Catalogue Number: 26265
• Device Lot Number: 0023239334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2019
• 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 Age: 65 YR
• Patient Weight: 50