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

Model Number	M00565060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bowel Perforation (2668); No Code Available (3191)
Date of Event	06/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex colonic stent was to be used to treat a malignant stricture obstructing the colon during an intestinal stent implantation procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.The patient's tissue was friable and the patient had undergone chemotherapy or radiation therapy.According to the complainant, during stent placement, the stent "got through from the lateral wall of the intestines".The physician felt that the intestinal wall was perforated and the stent was removed from the patient fully covered by the outer sheath.Another wallflex colonic stent was implanted to complete the procedure.The patient's condition at the conclusion of the procedure was reported to be stable.Fluoroscopy was performed and confirmed the perforation.Reportedly, the physician was uncertain what caused the perforation.The patient underwent intestinal colostomy to treat the perforation.
Event or Problem Description
It was reported to boston scientific corporation on june 25, 2019 that a wallflex colonic stent was to be used to treat a malignant stricture obstructing the colon during an intestinal stent implantation procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.The patient's tissue was friable and the patient had undergone chemotherapy or radiation therapy.According to the complainant, during stent placement, the stent "got through from the lateral wall of the intestines".The physician felt that the intestinal wall was perforated and the stent was removed from the patient fully covered by the outer sheath.Another wallflex colonic stent was implanted to complete the procedure.The patient's condition at the conclusion of the procedure was reported to be stable.Fluoroscopy was performed and confirmed the perforation.Reportedly, the physician was uncertain what caused the perforation.The patient underwent intestinal colostomy to treat the perforation.
Additional Manufacturer Narrative
Initial reporter's address1: (b)(6).Patient code 2668 captures the reportable event of bowel perforation patient code 3191 captures the surgical procedure " intestinal colostomy" a wallfex colonic stent and delivery system were received for analysis.Visual examination of the returned device found the stent was received undeployed and was fully covered by the outer sheath.A kink was noted in the stainless steel tube.Functional evaluation revealed that the stent could not be deployed as received, however; the stent was deployed manually by gripping the outer sheath and pulling the tip distally.The stent was measured to be within specifications.No other issues with the stent and delivery system were noted.The damage to the stainless steel tube was consistent with the application of excessive force during use.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.Additionally, perforation is noted within the dfu as a potential adverse event associated with the use of this device.Therefore, the most probable root cause is known inherent risk of device.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

• Brand Name: WALLFLEX COLONIC
• Common Device Name: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8805106
• Report Number: 3005099803-2019-03468
• Device Sequence Number: 326871
• Product Code: MQR
• UDI-Device Identifier: 08714729456537
• UDI-Public: 08714729456537
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2019

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: 07/30/2020
• Device Model Number: M00565060
• Device Catalogue Number: 6506
• Device Lot Number: 0022448763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 08/21/2019
• 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: 65 YR
• Patient Weight: 82