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

Model Number	M00565590
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Positioning Problem (3009)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	07/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that a wallstent enteral endoprosthesis stent was to be implanted to treat a malignant colonic obstruction during a stent placement procedure performed on (b)(6) 2022.During the procedure, when the wallstent enteral stent was attempted to be deployed, it was unable to deploy.Another attempt to deploy the wallstent enteral stent was performed and force was applied; however, the wallstent enteral stent was deployed in an incorrect location and had punctured the intestinal wall which resulted in perforation.Consequently, an emergency surgery was performed.The procedure was completed with another wallstent enteral stent.The patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
(b)(4).The wallstent enteral stent has not been received for analysis.Upon receipt and completion of the device analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Blocks b5 and e1 (initial reporter address 1, initial reporter address 2, city, zip/post code) have been updated with additional information received on (b)(6), 2022.Block h6: medical device problem code 1502 captures the reportable event of stent positioning issue.Patient code e2114 captures the reportable event of perforation.Impact code f19 captures the reportable event of emergency surgery performed to address the perforation.Block h10: the wallstent enteral stent has not been received for analysis.Upon receipt and completion of the device analysis, 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 on (b)(6) 2022 that a wallstent enteral endoprosthesis stent was to be implanted to treat a malignant colonic obstruction during a stent placement procedure performed on (b)(6), 2022.During the procedure, when the wallstent enteral stent was attempted to be deployed, it was unable to deploy.Another attempt to deploy the wallstent enteral stent was performed and force was applied; however, the wallstent enteral stent was deployed in an incorrect location and had punctured the intestinal wall which resulted in perforation.Consequently, an emergency surgery was performed.The procedure was completed with another wallstent enteral stent.The patient's condition following the procedure was reported to be stable.Additional information received on august 02, 2022.The wallstent enteral endoprosthesis stent was to be implanted to treat a 5cm malignant colonic obstruction.The patient's anatomy was tortuous.A colorectal surgery was performed to address the perforation and to remove the wallstent enteral stent.
Additional Manufacturer Narrative
Block h6: medical device problem code a1502 captures the reportable event of stent positioning issue.Patient code e2114 captures the reportable event of perforation.Impact code f19 captures the reportable event of emergency surgery performed to address the perforation.Block h10: a wallstent enteral colonic delivery system was received for analysis; the stent was not returned.Visual inspection found the outer clear sheath kinked.No other issues were noted to the delivery system.The reported events of stent positioning issue and stent difficult to deploy could not be confirmed as these occurred during the procedure and are not possible to replicate in the laboratory of analysis.It is likely that the patient's tortuous anatomy contributed to the difficulty in deploying the stent and caused the observed problem of sheath kinked.A product labeling review identified that the device was not used in accordance with the directions for use (dfu) / product label.The dfu cited: "pushing on the delivery system may cause misalignment of the stent and possible intestinal wall damage.The stent should deploy easily.Do not deploy the stent if unusual force is required, since this may indicate a failed device." the complainant reported that another attempt to deploy the wallstent enteral stent was performed and force was applied; however, the wallstent enteral stent was deployed in an incorrect location and had punctured the intestinal wall which resulted in perforation.Furthermore, perforation is noted within the dfu as a potential adverse event complication associated with the use of the device.The reported events are traced to the user not following the manufacturer's instructions.Therefore, a review and analysis of all available information indicated the most probable cause is failure to follow instructions.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that a wallstent enteral endoprosthesis stent was to be implanted to treat a malignant colonic obstruction during a stent placement procedure performed on (b)(6) 2022.During the procedure, when the wallstent enteral stent was attempted to be deployed, it was unable to deploy.Another attempt to deploy the wallstent enteral stent was performed and force was applied; however, the wallstent enteral stent was deployed in an incorrect location and had punctured the intestinal wall which resulted in perforation.Consequently, an emergency surgery was performed.The procedure was completed with another wallstent enteral stent.The patient's condition following the procedure was reported to be stable.Additional information received on august 02, 2022: the wallstent enteral endoprosthesis stent was to be implanted to treat a 5cm malignant colonic obstruction.The patient's anatomy was tortuous.A colorectal surgery was performed to address the perforation and to remove the wallstent enteral stent.

• 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
• 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: 15145718
• Report Number: 3005099803-2022-04138
• Device Sequence Number: 12070694
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2023
• Device Model Number: M00565590
• Device Catalogue Number: 6559
• Device Lot Number: 0026910981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2022
• Supplement Date Received by Manufacturer: 08/02/2022; 09/08/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 08/23/2022; 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 75 KG