MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX? COLONIC; STENT, COLONIC, METALIC, EXPANDABLE

Model Number M00565100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); Tissue Damage (2104)

Event Date 06/12/2014

Event Type  Injury  

Event Description

Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report # 3005099803-2014-02462, 3005099803-2014-02445 and 3005099803-2014-02469 for the associated device information.It was reported to boston scientific corporation that a wallflex enteral colonic stent, a tandem cannula, and a jagwire guidewire were used in the rectum during a stent placement procedure performed on (b)(6), 2014.According to the complainant, the stent was implanted to treat a stricture 6 cm from the entrance of the rectum.Reportedly, the patient¿s anatomy was tortuous.During the procedure, a jagwire guidewire and a tandem were advanced to the lesion and contrast radiography was performed.The physician removed the tandem and advanced the wallflex enteral colonic stent to the stricture.The stent was able to advance 1cm into the stenosis but then resistance was felt.The physician attempted to further advance the stent by slightly pulling the guidewire while advancing the stent.The jagwire guidewire and wallflex enteral colonic stent were removed from the patient.The physician inserted a tandem and performed radiography using urografin which showed the abdominal cavity.It was reported that an emergency operation was performed.Despite numerous attempts boston scientific has been unable obtain additional information regarding the circumstances surrounding this event.Should additional relevant details become available a supplemental report will be submitted.

Manufacturer Narrative

(b)(4): the complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date the complainant indicated that the device was disposed 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 medwatch will be filed.

Event Description

Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report # 3005099803-2014-02462 and 3005099803-2014-02469 for the associated device information.It was reported to boston scientific corporation that a wallflex enteral colonic stent, a tandem cannula, and a jagwire guidewire were used in the rectum during a stent placement procedure performed on (b)(6) 2014.According to the complainant, the stent was implanted to treat a stricture 6 cm from the entrance of the rectum.Reportedly, the patient's anatomy was tortuous.During the procedure, a jagwire guidewire and a tandem were advanced to the lesion and contrast radiography was performed.The physician removed the tandem and advanced the wallflex enteral colonic stent to the stricture.The stent was able to advance 1cm into the stenosis but then resistance was felt.The physician attempted to further advance the stent by slightly pulling the guidewire while advancing the stent.It was then reported that a perforation was noted in the intestinal tract.The jagwire guidewire and wallflex enteral colonic stent were removed from the patient.The physician inserted a tandem and performed radiography using urografin which showed the abdominal cavity.It was reported that an emergency operation was performed.Despite numerous attempts boston scientific has been unable obtain additional information regarding the circumstances surrounding this event.Should additional relevant details become available a supplemental report will be submitted.

Manufacturer Narrative

Lot number received october 3, 2014; the device was disposed; therefore, a technical analysis could not be performed.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.Perforation is listed in the dfu for this product as a potential post stent placement complication related to the use of this device.Therefore, the most probable root cause classification of the investigation is anticipated procedural complication.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications.  a search of the complaint database revealed that no similar complaints exist for the specified lot.

Event Description

Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report # 3005099803-2014-02462, 3005099803-2014-02445 and 3005099803-2014-02469 for the associated device information.It was reported to boston scientific corporation that a wallflex enteral colonic stent, a tandem cannula, and a jagwire guidewire were used in the rectum during a stent placement procedure performed on june 12, 2014.According to the complainant, the stent was implanted to treat a stricture 6 cm from the entrance of the rectum.Reportedly, the patient's anatomy was tortuous.During the procedure, a jagwire guidewire and a tandem were advanced to the lesion and contrast radiography was performed.The physician removed the tandem and advanced the wallflex enteral colonic stent to the stricture.The stent was able to advance 1cm into the stenosis but then resistance was felt.The physician attempted to further advance the stent by slightly pulling the guidewire while advancing the stent.It was then reported that a perforation was noted in the intestinal tract.The jagwire guidewire and wallflex enteral colonic stent were removed from the patient.The physician inserted a tandem and performed radiography using urografin which showed the abdominal cavity.It was reported that an emergency operation was performed.Additional information received on july 6, 2014.According to the complainant, the stent was implanted to treat a 4 cm malignant stricture in the rectum due to colon cancer.In the physician's assessment, the wallflex enteral colonic stent and jagwire guidewire caused the perforation and the tandem xl ercp cannula was not associated with the perforation.The patient was sent to surgery to treat the perforation.It was reported "during surgery for perforation, it was noticed damage to the ureter." it is unknown whether the stent or the guidewire contributed to the damage in the ureter.Additionally, no issues with the stent, guidewire and cannula were seen during use.Additional information received on august 10, 2014.The location of the perforation was clarified to have been in the rectum above the peritoneal reflection.In the physician's assessment, the damage to the ureter was related to the stent delivery system.

Event Description

Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report # 3005099803-2014-02462, 3005099803-2014-02445 and 3005099803-2014-02469 for the associated device information.It was reported to boston scientific corporation that a wallflex enteral colonic stent, a tandem cannula, and a jagwire guidewire were used in the rectum during a stent placement procedure performed on june 12, 2014.According to the complainant, the stent was implanted to treat a stricture 6 cm from the entrance of the rectum.Reportedly, the patient's anatomy was tortuous.During the procedure, a jagwire guidewire and a tandem were advanced to the lesion and contrast radiography was performed.The physician removed the tandem and advanced the wallflex enteral colonic stent to the stricture.The stent was able to advance 1cm into the stenosis but then resistance was felt.The physician attempted to further advance the stent by slightly pulling the guidewire while advancing the stent.It was then reported that a perforation was noted in the intestinal tract.The jagwire guidewire and wallflex enteral colonic stent were removed from the patient.The physician inserted a tandem and performed radiography using urografin which showed the abdominal cavity.It was reported that an emergency operation was performed.Additional information received on july 6, 2014.According to the complainant, the stent was implanted to treat a 4 cm malignant stricture in the rectum due to colon cancer.In the physician's assessment, the wallflex enteral colonic stent and jagwire guidewire caused the perforation and the tandem xl ercp cannula was not associated with the perforation.The patient was sent to surgery to treat the perforation.It was reported "during surgery for perforation, it was noticed damage to the ureter." it is unknown whether the stent or the guidewire contributed to the damage in the ureter.Additionally, no issues with the stent, guidewire and cannula were seen during use.Additional information received on august 10, 2014 the location of the perforation was clarified to have been in the rectum above the peritoneal reflection.In the physician's assessment, the damage to the ureter was related to the stent delivery system.

Manufacturer Narrative

The device was not returned; therefore, a technical analysis could not be performed.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.  perforation is listed in the dfu for this product as a potential post stent placement complication related to the use of this device.Therefore, the most probable root cause is anticipated procedural complication.

Event Description

Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report # 3005099803-2014-02462, 3005099803-2014-02445 and 3005099803-2014-02469 for the associated device information.It was reported to boston scientific corporation that a wallflex enteral colonic stent, a tandem cannula, and a jagwire guidewire were used in the rectum during a stent placement procedure performed on (b)(6) 2014.According to the complainant, the stent was implanted to treat a stricture 6 cm from the entrance of the rectum.Reportedly, the patient's anatomy was tortuous.During the procedure, a jagwire guidewire and a tandem were advanced to the lesion and contrast radiography was performed.The physician removed the tandem and advanced the wallflex enteral colonic stent to the stricture.The stent was able to advance 1cm into the stenosis but then resistance was felt.The physician attempted to further advance the stent by slightly pulling the guidewire while advancing the stent.The jagwire guidewire and wallflex enteral colonic stent were removed from the patient.The physician inserted a tandem and performed radiography using urografin which showed the abdominal cavity.It was reported that an emergency operation was performed.**additional information received on july 6, 2014.** according to the complainant, the stent was implanted to treat a 4 cm malignant stricture in the rectum due to colon cancer.In the physician's assessment, the wallflex enteral colonic stent and jagwire guidewire caused the perforation and the tandem xl ercp cannula was not associated with the perforation.The patient was sent to surgery to treat the perforation.It was reported 섕ring surgery for perforation, it was noticed damage to the ureter.� it is unknown whether the stent or the guidewire contributed to the damage in the ureter.Additionally, no issues with the stent, guidewire and cannula were seen during use.Boston scientific has been unable obtain additional information regarding the circumstances surrounding the ureter damage to date.Should additional relevant details become available a supplemental report will be submitted.

• Brand Name: WALLFLEX? COLONIC
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3910267
• MDR Text Key: 4492934
• Report Number: 3005099803-2014-02445
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/12/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2016
• Device Model Number: M00565100
• Device Catalogue Number: 6510
• Device Lot Number: 16889742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2014
• Initial Date FDA Received: 07/02/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/07/2014; 08/04/2014; 09/04/2014; 10/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2014
• 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