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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLSTENT? ENTERAL ENDOPROSTHESIS; STENT, COLONIC, METALIC, EXPANDABLE
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BOSTON SCIENTIFIC - GALWAY WALLSTENT? ENTERAL ENDOPROSTHESIS; STENT, COLONIC, METALIC, EXPANDABLE Back to Search Results
Model Number M00565590
Device Problems Material Perforation (2205); Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/05/2014
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a wallstent enteral stent was used in the second part of the duodenum during a stent placement procedure performed on (b)(6) 2014.According to the complainant, the stent was used to treat a 5cm malignant stricture.Reportedly, the patient¿s anatomy was not tortuous.During the procedure, the physician attempted to deploy the stent when a strong resistance was felt and the outer sheath could not be retracted.The stent was removed from the patient and it was noted that 2 wires of the stent perforated the distal sheath.The physician cut the distal 2 cm tip of the catheter and reinserted the stent to patient but the stent was not able to be fully deployed.The stent was removed from the patient partially deployed 1-2cm.The procedure was completed with another wallstent enteral stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
A visual examination of the returned device found that the stent was received fully mounted onto the delivery system.It was noted that the tip section of the catheter had been removed prior to receipt and the t-bar connector was detached from the outer sheath.The stent was able to be deployed during analysis by manually retracting the outer sheath and a visual examination confirmed that the distal end of the stent was damaged.It was noted that some of the wires were uncrossed and raised vertically.This damage may have occurred during the stent wire perforation through the outer sheath and when the distal end of the device was cut.The dark blue outer sheath had fully detached from the valve body.This type of damage is consistent with excessive force being applied to the delivery system.Glue was attached to the t-bar connector indicating that it had been bonded to the outer sheath as required during manufacture.A visual and tactile examination confirmed that the dark blue outer sheath was kinked 16cm distal to the proximal end of the outer sheath.The outer sheath was also stretched and accordioned at several positions along its length.A visual and microscopic examination of the inner catheter identified several kinks along its length.There were no issues noted with the profile of the stent holder.No other issues were identified during the product analysis.The noted damages were likely due to procedural or anatomical factors encountered during the procedure such as tortuous anatomy or maneuvering of the device.Therefore, the most probable root cause for this complaint is operational context.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications.There was evidence that the device was used in a manner inconsistent with the labelled indications.The physician cut the distal tip off the delivery system and reinserted the device after discovering that the stent wires had perforated the outer sheath.The following precaution is stated in the dfu: ¿if sterility or performance of the device is suspected to be compromised, it should not be used¿.
 
Event Description
It was reported to boston scientific corporation that a wallstent enteral stent was used in the second part of the duodenum during a stent placement procedure performed on (b)(6) 2014.According to the complainant, the stent was used to treat a 5cm malignant stricture.Reportedly, the patient¿s anatomy was not tortuous.During the procedure, the physician attempted to deploy the stent when a strong resistance was felt and the outer sheath could not be retracted.The stent was removed from the patient and it was noted that 2 wires of the stent perforated the distal sheath.The physician cut the distal 2 cm tip of the catheter and reinserted the stent to patient but the stent was not able to be fully deployed.The stent was removed from the patient partially deployed 1-2cm.The procedure was completed with another wallstent enteral stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
(b)(4) sheath wire perforation.(b)(4) stent partially deployed.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.
 
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Brand Name
WALLSTENT? ENTERAL ENDOPROSTHESIS
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 Key4198956
MDR Text Key5307201
Report Number3005099803-2014-03488
Device Sequence Number1
Product Code MQR
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K000281
Number of Events Reported1
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 10/05/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/08/2015
Device Model NumberM00565590
Device Catalogue Number6559
Device Lot Number16520599
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/17/2014
Initial Date FDA Received10/24/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/09/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/12/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age73 YR
Patient Weight65
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