MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC; STENT, COLONIC, METALIC, EXPANDABLE

Model Number	M00565060
Medical Device Problem Codes	Premature Activation (1484); Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022, that a wallflex enteral colonic stent was to be implanted in the spleen to treat a splenomegaly during a colonoscopy procedure performed on (b)(6) 2022.The patient's anatomy was tortuous.During the procedure, the wallflex colonic stent could not be deployed.The wallflex colonic stent fully deployed when it was removed from the patient.The procedure was completed with another wallflex colonic stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.It was reported that the stent was to be implanted to treat splenomegaly.However, per the wallflex colonic stent system with anchor lock delivery system directions for use, the stent is indicated for the palliative treatment of colonic strictures produced by malignant neoplasm and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Blocks b5 has been updated with the additional information received on (b)(6), 2022.Block h6: imdrf device code a150103 captures the reportable event of stent prematurely deployed.Block h10: the wallflex colonic stent and delivery system were received for analysis.The stent was received fully covered by the outer sheath and undeployed.Visual examination of the returned device found the outer clear sheath kinked.A functional inspection was performed, and the stent was deployed without problems by actuating the delivery system (slide the handle back along the stainless-steel tube).No other issues were noted to the stent and delivery system.The investigation concluded that the observed failure of outer clear sheath kinked was likely due to the patient anatomy (tortuous).It may be that an existing condition or disease, limited the performance of the device and contributed to the outer clear sheath kinked.The reported event of stent partially deployed cannot be confirmed.Taking all available information into consideration, the investigation concluded that there is not enough information to confirm the reported event as the stent was not returned.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022, that a wallflex enteral colonic stent was to be implanted in the spleen to treat a splenomegaly during a colonoscopy procedure performed on (b)(6), 2022.The patient's anatomy was tortuous.During the procedure, the wallflex colonic stent could not be deployed.The wallflex colonic stent fully deployed when it was removed from the patient.The procedure was completed with another wallflex colonic stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.***additional information received on (b)(6)2022*** it was reported that the stent was partially deployed when removed from the patient.
Additional Manufacturer Narrative
Blocks b5 has been updated with the additional information received on november 08, 2022.Block h6: imdrf device code a150103 captures the reportable event of stent prematurely deployed.
Event or Problem Description
It was reported to boston scientific corporation on october 11, 2022, that a wallflex enteral colonic stent was to be implanted in the spleen to treat a splenomegaly during a colonoscopy procedure performed on (b)(6) 2022.The patient's anatomy was tortuous.During the procedure, the wallflex colonic stent could not be deployed.The wallflex colonic stent fully deployed when it was removed from the patient.The procedure was completed with another wallflex colonic stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: it was reported that the stent was to be implanted to treat splenomegaly.However, per the wallflex colonic stent system with anchor lock delivery system directions for use, the stent is indicated for the palliative treatment of colonic strictures produced by malignant neoplasm and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.Additional information received on november 08, 2022: it was reported that the stent was partially deployed when removed from the patient.

• Brand Name: WALLFLEX COLONIC
• Common Device Name: STENT, COLONIC, METALIC, EXPANDABLE
• 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: 15710511
• Report Number: 3005099803-2022-06391
• Device Sequence Number: 12384492
• Product Code: MQR
• UDI-Device Identifier: 08714729456537
• UDI-Public: 08714729456537
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2023
• Device Model Number: M00565060
• Device Catalogue Number: 6506
• Device Lot Number: 0028324977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2022
• Supplement Date Received by Manufacturer: 11/08/2022; 11/30/2022
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 11/29/2022; 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 65 KG