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

Model Number M00565060

Device Problems Premature Activation (1484); Failure to Advance (2524)

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

Event Date 11/18/2021

Event Type  malfunction  

Manufacturer Narrative

The initial reporter's address 2 is (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2021 that a wallflex colonic stent was implanted to treat a 9cm malignant intestinal obstruction during a stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was tortuous.During the procedure, there was difficulty in advancing the delivery system through the lesion and the stent prematurely deployed in the distal end of the stenosis.The stent remains implanted and another wallflex colonic stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block e1: the initial reporter's address 2 is (b)(6) block h6: medical device problem code a150103 captures the reportable event of stent premature deployment.Block h10: a wallflex colonic delivery system was received for analysis; the stent was not returned.Visual examination of the returned device did not find any damages to the delivery system.The reported events of stent premature deployment and delivery system difficult to cross lesion were related to the procedure; therefore, the events could not be confirmed as they could not be functionally/ visually verified.The reported events were most likely due to procedural and anatomical factors encountered during the procedure.The characteristics of the lesion, the tortuous anatomy of the patient, how the device was handled or manipulated, and/or the techniques used by the user most likely limited the performance of the device and contributed to stent premature deployment and delivery system difficult to cross lesion.However, the stent was not returned and there is not enough information or evidence to confirm the reported events.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation on (b)(6) 2021 that a wallflex colonic stent was implanted to treat a 9cm malignant intestinal obstruction during a stent placement procedure performed on (b)(6), 2021.Reportedly, the patient's anatomy was tortuous.During the procedure, there was difficulty in advancing the delivery system through the lesion and the stent prematurely deployed in the distal end of the stenosis.The stent remains implanted and another wallflex colonic stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: WALLFLEX COLONIC
• Type of Device: 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: 12985144
• MDR Text Key: 282203209
• Report Number: 3005099803-2021-07409
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729456537
• UDI-Public: 08714729456537
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K061877
• 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: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2022
• Device Model Number: M00565060
• Device Catalogue Number: 6506
• Device Lot Number: 0025496639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2020
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 62 KG