MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM; STENT, COLONIC, METALIC, EXPANDABLE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problems Death (1802); Perforation (2001)

Event Date 12/01/2018

Event Type  Death  

Manufacturer Narrative

Date of event was approximated to be (b)(6) 2018 as no specific event date was reported.The complainant was unable to provide the upn and lot number.Therefore, the manufacture and expiration dates are unknown.(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 Description

Note: refer to manufacturer report # 3005099803-2018-62298 and 3005099803-2018-62300 for the associated device information.It was reported to boston scientific corporation on (b)(6) 2018 that two wallflex colonic stents had been implanted in a patient's colon during a colonic stent placement procedure performed on an unknown date about a year ago.According to the complainant, the patient perforated before the two stents came together.The patient expired twelve hours after the procedure.Despite numerous attempts, boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

Date of event was approximated to be (b)(6) 2018 as no specific event date was reported.The complainant was unable to provide the upn and lot number.Therefore, the manufacture and expiration dates are unknown.Problem code 3009 captures the reportable event of stent positioning problem.Patient code 2001 captures the reportable event of perforation.Patient code 1802 captures the reportable event of death.The complainant indicated that the suspect device remains implanted 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 mdr will be filed.

Event Description

Note: refer to manufacturer report # 3005099803-2018-62298 and 3005099803-2018-62300 for the associated device information.It was reported to boston scientific corporation on december 10, 2018 that two wallflex colonic stents had been implanted in a patient's colon during a colonic stent placement procedure performed on an unknown date about a year ago.According to the complainant, the patient perforated before the two stents came together.The patient expired twelve hours after the procedure.Additional information received on january 11, 2019.It was reported that the two wallflex colonic stents were implanted to treat a malignancy.The patient's tissue was friable and they had a tight turn in the bowel, which, according to the complainant, may have contributed to their death.The first wallflex colonic stent was deployed in an incorrect location; the stent was not fully bridging the stricture.A second wallflex colonic stent was implanted stent-in-stent in the first stent.Reportedly, the clinical cause of the patient's death was perforation.Per the physician, placing two overlapping stents could have potentially contributed to the perforation.

• Brand Name: WALLFLEX COLONIC SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8216975
• MDR Text Key: 132059968
• Report Number: 3005099803-2018-62298
• Device Sequence Number: 1
• Product Code: MQR
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/06/2019

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 01/11/2019
• Supplement Dates FDA Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention