MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT ENTERAL ENDOPROSTHESIS; STENT, COLONIC, METALIC, EXPANDABLE

Model Number	M00565590
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent enteral uncovered stent was to be implanted to treat a 6-7cm colorectal malignant tumor in the rectum during an intestinal stent implantation performed on (b)(6) 2020.Reportedly, the patient's anatomy was not tortuous prior to stent placement.According to the complainant, during the procedure, when the stent was fully deployed in the rectum, it was noted that the stent wire at the tip became split and pierced the patient's mucosa causing severe bleeding.Reportedly, the physician was able to remove the stent out of the rectum manually and the procedure was completed with another wallstent enteral stent.The patient received drug therapy treatment to address the bleeding.The patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: patient code 2001 captures the reportable event of perforation.Patient code 1888 captures the reportable event of hemorrhage.Device problem code 2976 captures the reportable event of stent material deformation.Block h10: a wallstent enteral uncovered stent and delivery system were received for analysis.The stent was received completely deployed.Visual examination found that the wires of the stent was broken and unraveled.The outer diameter and stent length were measured and were found to be within specification.No other issues were noted to the stent and delivery system.The reported event of stent material deformation was confirmed as the wires of the stent were broken and unraveled.It may be that the technique used by the user during the stent deployment limited the performance of the device and contributed to the damage on the stent which caused hemorrhage and perforation.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Hemorrhage and perforation are noted within the ifu as a potential adverse event associated with the use of this device.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.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent enteral uncovered stent was to be implanted to treat a 6-7cm colorectal malignant tumor in the rectum during an intestinal stent implantation performed on (b)(6) 2020.Reportedly, the patient's anatomy was not tortuous prior to stent placement.According to the complainant, during the procedure, when the stent was fully deployed in the rectum, it was noted that the stent wire at the tip became split and pierced the patient's mucosa causing severe bleeding.Reportedly, the physician was able to remove the stent out of the rectum manually and the procedure was completed with another wallstent enteral stent.The patient received drug therapy treatment to address the bleeding.The patient's condition following the procedure was reported to be stable.

• Brand Name: WALLSTENT ENTERAL ENDOPROSTHESIS
• Common Device Name: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11069062
• Report Number: 3005099803-2020-06417
• Device Sequence Number: 19499895
• Product Code: MQR
• UDI-Device Identifier: 08714729285083
• UDI-Public: 08714729285083
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K000281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/10/2021
• Device Model Number: M00565590
• Device Catalogue Number: 6559
• Device Lot Number: 0024581161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 49