MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC

Model Number 26280

Device Problems Stretched (1601); Activation Failure (3270)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331)

Event Date 12/07/2018

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that the stent failed to fully open and the patient experienced pain.The 14mm diameter target lesion was located in the renal vein.After the 260cm amplatz was passed through, a 14x40/9fr uni plus 75cm wallstent endoprosthesis was used for treatment.However, the stent failed to fully expand and then became too long to touch the inferior vena cava (ivc).The patient began to feel pain.When the physician looked at the image, he found out that the aorta and the superior mesenteric artery were oppressed and thought it might have caused the wallstent to not to fully expand.The physician worried about ivc rupture.The patient was arranged for prolonged hospitalization and observation.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• 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: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8153284
• MDR Text Key: 130020548
• Report Number: 2134265-2018-63849
• Device Sequence Number: 1
• Product Code: MAF
• UDI-Device Identifier: 08714729203995
• UDI-Public: 08714729203995
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K152842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2019
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0021045848
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2017
• 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): Hospitalization