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

Model Number M00565040

Device Problems Break (1069); Difficult to Remove (1528); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated that the device was contaminated and will not be returned for evaluation; therefore, a failure 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) 2020 that a wallflex colonic stent was implanted to treat a tumor in the colon during a colonic stenting procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was successfully deployed confirmed by the x-ray image; however, there was a lot of resistance to remove the delivery system.Reportedly, the delivery system was removed; however, it was noted that the stent was broken and deformed.The stent was removed using a rat tooth forceps and another wallflex colonic stent was implanted to complete the procedure.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: a photo of the complaint device post procedure was provided by the complainant and it showed a broken and deformed stent.

Manufacturer Narrative

Block h6: problem code 1069 captures the reportable event of stent broken.Problem code 2976 captures the reportable event of stent deformed.Problem code 1528 captures the reportable event of delivery system difficult to remove.Block h10: the hot axios stent was received for analysis; the delivery system was not returned.Visual examination of the returned device found the stent wires were broken, kinked and unraveled.A media inspection of a photo provided by the complaint after the procedure also noted the stent wires were broken, kinked and unraveled.No other damages were noted to the stent.The reported events of stent break and stent material deformation were confirmed.However, the reported event of delivery system difficult to remove could not be confirmed; this event occurred during procedure and it is not possible to replicate this event in the laboratory.The investigation concluded that the reported events and the observed failures were likely due to anatomical and procedural factors encountered during the procedure.It may be that the techniques used by the user and the patient's tight anatomy could have caused damage to the stent during deployment resulting in inadequate stent flexibility and resistance while removing the delivery system.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/ product label.

Event Description

It was reported to boston scientific corporation on november 20, 2020 that a wallflex colonic stent was implanted to treat a tumor in the colon during a colonic stenting procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was successfully deployed confirmed by the x-ray image; however, there was a lot of resistance to remove the delivery system.Reportedly, the delivery system was removed; however, it was noted that the stent was broken and deformed.The stent was removed using a rat tooth forceps and another wallflex colonic stent was implanted to complete the procedure.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: a photo of the complaint device post procedure was provided by the complainant and it showed a broken and deformed stent.

Event Description

It was reported to boston scientific corporation on (b)(6) 2020 that a wallflex colonic stent was implanted to treat a tumor in the colon during a colonic stenting procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was successfully deployed confirmed by the x-ray image; however, there was a lot of resistance to remove the delivery system.Reportedly, the delivery system was removed; however, it was noted that the stent was broken and deformed.The stent was removed using a rat tooth forceps and another wallflex colonic stent was implanted to complete the procedure.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: a photo of the complaint device post procedure was provided by the complainant and it showed a broken and deformed stent.

Manufacturer Narrative

Block h6: problem code 1069 captures the reportable event of stent broken.Problem code 2976 captures the reportable event of stent deformed.Problem code 1528 captures the reportable event of delivery system difficult to remove.Block h10: a wallflex colonic stent was received for analysis; the delivery system was not returned.Visual examination of the returned device found the stent wires were broken, kinked and unraveled.A media inspection of a photo provided by the complaint after the procedure also noted the stent wires were broken, kinked and unraveled.No other damages were noted to the stent.The reported events of stent break and stent material deformation were confirmed.However, the reported event of delivery system difficult to remove could not be confirmed; this event occurred during procedure and it is not possible to replicate this event in the laboratory.The investigation concluded that the reported events and the observed failures were likely due to anatomical and procedural factors encountered during the procedure.It may be that the techniques used by the user and the patient's tight anatomy could have caused damage to the stent during deployment resulting in inadequate stent flexibility and resistance while removing the delivery system.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/ product label.Block h11: block h10 has been corrected.

• Brand Name: WALLFLEX COLONIC
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10983887
• MDR Text Key: 220681150
• Report Number: 3005099803-2020-06001
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729456513
• UDI-Public: 08714729456513
• Combination Product (y/n): N
• PMA/PMN Number: K061877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2021

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: 01/05/2022
• Device Model Number: M00565040
• Device Catalogue Number: 6504
• Device Lot Number: 0024989371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 02/18/2021; 02/18/2021
• Supplement Dates FDA Received: 03/10/2021; 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention