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

Model Number M00565110

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

Patient Problem Perforation (2001)

Event Date 10/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient's exact age is unknown; however it was reported that the patient was over the age of 18.The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

Note: this report pertains to one of the two devices used during the same procedure.Refer to manufacturer report # 3005099803-2016-03445 for the wallflex enteral colonic stent and 3005099803-2016-03431 for the jagwire.It was reported to boston scientific corporation on (b)(6) 2016 that a wallflex enteral colonic stent and a jagwire guidewire were used in the sigmoid colon during a stent placement procedure performed on (b)(6) 2016.The indication for stent placement was as palliative care to treat a malignant stricture due to large intestine cancer.Reportedly, the patients anatomy was tortuous and the patient had no previous chemotherapy or radiation therapy.According to the complainant, during the procedure, the physician inserted the wallflex enteral colonic stent (the subject to mfr report # 3005099803-2016-03445) over the jagwire guidewire (the subject mfr report # 3005099803-2016-03431).The physician experienced difficulty crossing the wallflex and jagwire through the tortuous anatomy and it was noted that the patient started experiencing pain.Contrast imaging was done before deploying the stent and it was noted that the contrast agent was found leaking out of the intestinal tract and a perforation was confirmed.The stent and the guidewire were removed.The patient underwent a surgery where the tumor and the perforation were resected.According to the complainant, in the physicians assessment, the delivery system of the stent and the guidwire contributed to the perforation.The patient condition at the conclusion of the surgery was reported to be stable and there were no other patient complications reported.

Manufacturer Narrative

Investigation results: a wallflex colonic stent and delivery system was returned for analysis.The stent was not deployed.No issues were noted with the device.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.Perforation and pain are known potential complications associated with the use of this device, and are listed in the directions for use (dfu) / product label.Therefore, the root cause of this complaint is anticipated procedural complications.A search of the complaint database confirmed that no similar complaints exist for the specified lot.

Event Description

Note: this report pertains to one of the two devices used during the same procedure.Refer to manufacturer report # 3005099803-2016-03445 for the wallflex enteral colonic stent and 3005099803-2016-03431 for the jagwire.It was reported to boston scientific corporation on (b)(6) 2016 that a wallflex enteral colonic stent and a jagwire guidewire were used in the sigmoid colon during a stent placement procedure performed on (b)(6) 2016.The indication for stent placement was as palliative care to treat a malignant stricture due to large intestine cancer.Reportedly, the patient¿s anatomy was tortuous and the patient had no previous chemotherapy or radiation therapy.According to the complainant, during the procedure, the physician inserted the wallflex enteral colonic stent (the subject to mfr report # 3005099803-2016-03445) over the jagwire guidewire (the subject mfr report # 3005099803-2016-03431).The physician experienced difficulty crossing the wallflex and jagwire through the tortuous anatomy and it was noted that the patient started experiencing pain.Contrast imaging was done before deploying the stent and it was noted that the contrast agent was found leaking out of the intestinal tract and a perforation was confirmed.The stent and the guidewire were removed.The patient underwent a surgery where the tumor and the perforation were resected.According to the complainant, in the physician¿s assessment, the delivery system of the stent and the guidwire contributed to the perforation.The patient condition at the conclusion of the surgery was reported to be stable and there were no other patient complications reported.

• Brand Name: WALLFLEX¿ COLONIC
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6106744
• MDR Text Key: 60035094
• Report Number: 3005099803-2016-03445
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2016

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: 07/05/2018
• Device Model Number: M00565110
• Device Catalogue Number: 6511
• Device Lot Number: 0019444060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2016
• Initial Date FDA Received: 11/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2016
• 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