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

Model Number M00565590

Device Problems Break (1069); Human-Device Interface Problem (2949)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/04/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation on (b)(6) 2022 that a wallstent enteral uncovered stent was to be implanted in the intestinal tract to treat a 5 cm tumor during a stent placement procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous.During the procedure, the stent was deployed; however, the metal stent wire was loose and scratched the intestinal tract.Under a scope bleeding was noted.A clip and a drug were used to stop the bleeding.The stent was removed from the patient using forceps and the procedure was completed with another wallstent enteral stent.The patient's condition at the conclusion of the procedure was reported to be stable.In the physician's opinion the stent design is not good to adapt to the patient.

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

Block h6: medical device problem code a0401 captures the reportable event of stent break.Block h10: a wallstent enteral stent and delivery system were received for analysis.The stent was returned completely deployed.Visual inspection of the returned device found the outer and inner sheath were kinked.The stent wires were found damage at one section.No other problems were noted to the stent and delivery system.The reported event of stent break was not confirmed; the stent was returned intact, however, the stent wires were found damage at one section.The damages noted to the sheath were most likely due to procedural factors encountered during the procedure.It may be that the lesion characteristics, how the device was handled or manipulated, the techniques used by the user and/or normal procedural difficulties encountered during the procedure, limited the performance of the device.Therefore, contributing to the kinking of the inner and outer sheath.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 product labeling review identified that the device was used per the directions for use (dfu) / product label.Additionally, hemorrhage is a known potential complication associated with the use of the device in the manufacturers labeling.

Event Description

It was reported to boston scientific corporation on march 07, 2022 that a wallstent enteral uncovered stent was to be implanted in the intestinal tract to treat a 5 cm tumor during a stent placement procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous.During the procedure, the stent was deployed; however, the metal stent wire was loose and scratched the intestinal tract.Under a scope bleeding was noted.A clip and a drug were used to stop the bleeding.The stent was removed from the patient using forceps and the procedure was completed with another wallstent enteral stent.The patient's condition at the conclusion of the procedure was reported to be stable.In the physician's opinion the stent design is not good to adapt to the patient.

• Brand Name: WALLSTENT ENTERAL ENDOPROSTHESIS
• 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: 13955504
• MDR Text Key: 288819593
• Report Number: 3005099803-2022-01650
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729285083
• UDI-Public: 08714729285083
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K000281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/19/2022

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: 06/12/2022
• Device Model Number: M00565590
• Device Catalogue Number: 6559
• Device Lot Number: 0025592025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 03/30/2022
• Supplement Dates Manufacturer Received: 07/28/2022
• Supplement Dates FDA Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2020
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 59 KG