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

Model Number M00565050

Device Problems Premature Activation (1484); Activation Failure (3270)

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

Event Date 02/02/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated the stent remains implanted 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 enteral colonic stent was to be implanted to treat a bowel obstruction in the transverse colon during a bridge to surgery stent placement procedure performed on (b)(6) 2022.Reportedly, the patient's anatomy was tortuous.During the procedure, the stent prematurely deployed into the colon.Another wallflex enteral colonic stent was successfully implanted and the mispositioned stent was pulled into the second stent using forceps.There were no patient complications as a result of this event.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

(b)(4).The complainant indicated the stent remains implanted 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 enteral colonic stent was to be implanted to treat a bowel obstruction in the transverse colon during a bridge to surgery stent placement procedure performed on (b)(6) 2022.Reportedly, the patient's anatomy was tortuous.During the procedure, the stent prematurely deployed into the colon.Another wallflex enteral colonic stent was successfully implanted and the mispositioned stent was pulled into the second stent using forceps.There were no patient complications as a result of this event.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex enteral colonic stent was to be implanted to treat a bowel obstruction in the transverse colon during a bridge to surgery stent placement procedure performed on (b)(6) 2022.Reportedly, the patient's anatomy was tortuous.During the procedure, the stent prematurely deployed into the colon.Another wallflex enteral colonic stent was successfully implanted and the mispositioned stent was pulled into the second stent using forceps.There were no patient complications as a result of this event.**additional information received on march 13, 2022** the prematurely deployed stent was unable to expand.The stent was repositioned with forceps and a second wallflex enteral colonic stent was implanted stent-in-stent to complete the procedure.

Manufacturer Narrative

Blocks b5 and h6 (device code) have been updated with additional information received on march 13, 2022.Block h6: medical device problem code a150103 captures the reportable event of stent prematurely deployed.Medical device problem code a150101 captures the reportable event of stent failure to expand.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated the stent remains implanted 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.

• 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: 13592213
• MDR Text Key: 286078521
• Report Number: 3005099803-2022-00966
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729456520
• UDI-Public: 08714729456520
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2023
• Device Model Number: M00565050
• Device Catalogue Number: 6505
• Device Lot Number: 0027866228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 03/13/2022
• Supplement Dates FDA Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• 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