MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX BILIARY RX STENT SYSTEM; CATHETER, BILIARY, DIAGNOSTIC

Model Number M00570490

Device Problems Use of Device Problem (1670); Difficult to Advance (2920); Activation Failure (3270); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2022

Event Type  Injury  

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Initial reporter's address: (b)(6).(b)(4).The complainant indicated that the device was contaminated and was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex fully covered biliary rmv stent was implanted percutaneously in the biliary to treat a haemobilia during a stent placement procedure performed on (b)(6) 2022.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the guide became stuck.The wallflex stent was able to be deployed; however, it was noted that the distal end of the stent did not fully expand.The stent remains implanted and the procedure was completed with this device.Four days post stent placement, the stent migrated and was removed from the colon.There were no patient complications reported as a result of this event.The patient condition after the procedure was reported to be okay.Note: according to the complainant, the wallflex biliary fully covered stent was used percutaneously to treat haemobilia.However, per the wallflex biliary rx fully covered stent system directions for use, the stent is intended to be placed endoscopically for use in the palliative treatment of biliary strictures produced by malignant neoplasms, relief of malignant biliary obstruction prior to surgery and for treatment of benign biliary strictures.The stent is not intended to be placed percutaneously to treat haemobilia.

Manufacturer Narrative

Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block b5 has been updated with additional information received on june 29, 2022.Block e1: initial reporter's address: (b)(6).Block h6: medical device problem code a150101 captures the reportable event of stent failure to expand.Medical device problem code a010402 captures the reportable event of stent migration.Impact code f23 captures the additional intervention of stent removal.Block h10: the complainant indicated that the device was contaminated and was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on june 06, 2022 that a wallflex fully covered biliary rmv stent was implanted percutaneously in the biliary to treat a haemobilia during a stent placement procedure performed on (b)(6) 2022.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the guide became stuck.The wallflex stent was able to be deployed; however, it was noted that the distal end of the stent did not fully expand.The stent remains implanted and the procedure was completed with this device.Four days post stent placement, the stent migrated and was removed from the colon.There were no patient complications reported as a result of this event.The patient condition after the procedure was reported to be okay.Note: according to the complainant, the wallflex biliary fully covered stent was used percutaneously to treat haemobilia.However, per the wallflex biliary rx fully covered stent system directions for use, the stent is intended to be placed endoscopically for use in the palliative treatment of biliary strictures produced by malignant neoplasms, relief of malignant biliary obstruction prior to surgery and for treatment of benign biliary strictures.The stent is not intended to be placed percutaneously to treat haemobilia.It was reported that additional pressure was required to advance the guidewire through the rapid exchange port.

• Brand Name: WALLFLEX BILIARY RX STENT SYSTEM
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14859594
• MDR Text Key: 295065328
• Report Number: 3005099803-2022-03477
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2024
• Device Model Number: M00570490
• Device Catalogue Number: 7049
• Device Lot Number: 0028642664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2022
• 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): Required Intervention
• Patient Sex: Female