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 03/20/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a wallflex enteral colonic stent was used during a stent-in-stent placement procedure in the splenic flexure performed on (b)(6) 2014.The first stent was placed without issue from the transverse colon to the splenic flexure.Reportedly, the patient¿s anatomy was tortuous.According to the physician, the 9cm stent was intended to be place from the splenic flexure to the descending colon.During the procedure, the physician inserted the delivery system into the desired location via a guidewire.During insertion, the tip of the delivery system came in contact with the wall of the large intestine and caused a slight perforation.Bleeding occurred at the perforation site, but was resolved without treatment and there was no intervention to address the perforation.The stent was advanced into the desired location and the physician noted that the delivery system was bent at a 90 degree angle.There was strong resistance when the physician attempted to release the stent and the stent was unable to be deployed.The stent was removed from the patient fully constrained on the delivery system.The procedure was not completed because another device was unavailable.According to the physician, there was a small gap between the outer sheath and the inner shaft which might have caused the delivery system to stick to the intestinal wall.In the physician¿s assessment, the gap was the cause of the slight perforation.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable and is being monitored.

Manufacturer Narrative

The device has been received for analysis.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.

Manufacturer Narrative

A visual examination of the returned device found that the stent was fully mounted on to the device.It was noted that the outer sheath was flush to the tip with no gap present.A bend was noted in the stainless steel handle.During analysis it was possible to deploy the stent without issue.The shaft was dissected at the proximal end of the clear outer sheath.The inner lumen was withdrawn from the outer sheath and no issues were noted with its profile.The proximal end of the outer sheath was dissected longitudinally and it was noted that polytetrafluoroethylene (ptfe) coating had partially peeled away from inside of the outer sheath.The investigation concluded that this complaint is associated with a product that meets design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.  therefore, the most probable root cause classification for the reported failure is operational context.A review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that a wallflex enteral colonic stent was used during a stent-in-stent placement procedure in the splenic flexure performed on (b)(6), 2014.The first stent was placed without issue from the transverse colon to the splenic flexure.Reportedly, the patient's anatomy was tortuous.According to the physician, the 9cm stent was intended to be place from the splenic flexure to the descending colon.During the procedure, the physician inserted the delivery system into the desired location via a guidewire.During insertion, the tip of the delivery system came in contact with the wall of the large intestine and caused a slight perforation.Bleeding occurred at the perforation site, but was resolved without treatment and there was no intervention to address the perforation.The stent was advanced into the desired location and the physician noted that the delivery system was bent at a 90 degree angle.There was strong resistance when the physician attempted to release the stent and the stent was unable to be deployed.The stent was removed from the patient fully constrained on the delivery system.The procedure was not completed because another device was unavailable.According to the physician, there was a small gap between the outer sheath and the inner shaft which might have caused the delivery system to stick to the intestinal wall.In the physician's assessment, the gap was the cause of the slight perforation.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable and is being monitored.

• 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: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3753813
• MDR Text Key: 4466922
• Report Number: 3005099803-2014-01761
• 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
• Report Date: 03/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/08/2015
• Device Model Number: M00565110
• Device Catalogue Number: 6511
• Device Lot Number: 16520671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2013
• 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): Other
• Patient Age: 85 YR