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

Model Number M00565050

Device Problems Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Activation Failure (3270)

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

Event Date 10/19/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated that the stent remains implanted and the delivery system was contaminated and disposed; 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) 2021 that a wallflex enteral colonic stent was implanted to treat an intestinal obstruction in the colon during a stent implantation performed on (b)(6) 2021.During the procedure, there was resistance when the stent was deployed and the two ends of the stent failed to expand once fully deployed.The stent was indwelled and could not be removed; the patient underwent a surgery.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block b5, d6a, h6 (device code) and block h10 have been updated with additional information received on november 12, 2021 and november 16, 2021.Block h6: impact code f19 is being used to capture the reportable surgical intervention.Medical device problem code a150101 captures the reportable event of stent failure to expand.Medical device poblem code a150207 captures the reportable event of stent difficult to remove.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the delivery system was contaminated and was disposed; 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) 2021 that a wallflex enteral colonic stent was implanted to treat an intestinal obstruction in the colon during a stent implantation performed on (b)(6) 2021.During the procedure, there was resistance when the stent was deployed and the two ends of the stent failed to expand once fully deployed.The stent was indwelled and could not be removed; the patient underwent a surgery.There were no patient complications reported as a result of this event.Additional information was received on november 12, 2021 and november 16, 2021 it was reported that the wallflex enteral colonic stent was implanted to treat a 5cm lesion obstructing the intestinal colon.After the stent was deployed inside the patient, imaging was performed and confirmed the stent did not expand.Reportedly, several attempts were made to remove the stent but it was unsuccessful.The patient was sent for surgery to cut the tumor and the stent was successfully removed using snares and forceps.The patient's condition following the procedure was reported to be fine.

• 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: 12771872
• MDR Text Key: 280471791
• Report Number: 3005099803-2021-05778
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729456520
• UDI-Public: 08714729456520
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2022
• Device Model Number: M00565050
• Device Catalogue Number: 6505
• Device Lot Number: 0025029193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 69 KG