MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX ¿ DUODENAL; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number M00565020

Device Problems Difficult to Remove (1528); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 01/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not been received for analysis; 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

It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex enteral duodenal stent was to be used to treat a 3 cm duodenal stricture during an esophagogastroduodenoscopy (egd) with metal stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was deployed in an incorrect location.The physician tried to withdraw the delivery system however, the delivery system got caught on the stent and could not be removed.The catheter was cut outside the scope, to remove the scope but leave the stent and delivery system within the patient.Surgery was performed in order to remove the stent and delivery system from the patient.A gastrojejunostomy (billroth ii and antrectomy) was performed to complete the procedure, treating the patient¿s underlying condition and allowing the patient to eat and drink.The patient's condition at the conclusion of the procedure was reported to be fine and started total parental nutrition (tpn).

Manufacturer Narrative

Although the suspect device has been received, 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 mdr will be filed.Additional information noted on (b)(6) 2018: a photo received from the customer was reviewed and it was noted that the stent was fully deployed outside the patient, and that the inner shaft was around the stent.It was also noted that there were several kinks along the inner shaft.

Event Description

It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex enteral duodenal stent was to be used to treat a 3 cm duodenal stricture during an esophagogastroduodenoscopy (egd) with metal stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was deployed in an incorrect location.The physician tried to withdraw the delivery system however, the delivery system got caught on the stent and could not be removed.The catheter was cut outside the scope, to remove the scope but leave the stent and delivery system within the patient.Surgery was performed in order to remove the stent and delivery system from the patient.A gastrojejunostomy (billroth ii and antrectomy) was performed to complete the procedure, treating the patient¿s underlying condition and allowing the patient to eat and drink.The patient's condition at the conclusion of the procedure was reported to be fine and started total parental nutrition (tpn).

Manufacturer Narrative

A deployed wallflex duodenal stent and a piece of the inner catheter were received for analysis; the delivery system was not returned.Visual examination of the returned device identified several kinks along the inner member and was broken.The stent was measured to be within specifications.There were no issues with the stent and no other issues with the device were noted.Device analysis determined the inner member was broken.The damage noted to the device was consistent with the application of excessive force during withdrawal of the stent.Taking all available information into consideration, the investigation concluded that the reported failure of stent placement problem was likely due to anatomical or procedural factors encountered during the procedure, such as the characteristics of lesion, which limited the performance of the device.Therefore, the most probable root cause is operational context.A labeling review was performed, and from the information available, this device was used per the directions for use (dfu)/product label.A review of the device history record (dhr) confirmed that the device met all material, assembly and product specifications at the time of release to distribution.A search of the complaint database revealed that no other similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex enteral duodenal stent was to be used to treat a 3 cm duodenal stricture during an esophagogastroduodenoscopy (egd) with metal stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was deployed in an incorrect location.The physician tried to withdraw the delivery system however, the delivery system got caught on the stent and could not be removed.The catheter was cut outside the scope, to remove the scope but leave the stent and delivery system within the patient.Surgery was performed in order to remove the stent and delivery system from the patient.A gastrojejunostomy (billroth ii and antrectomy) was performed to complete the procedure, treating the patient¿s underlying condition and allowing the patient to eat and drink.The patient's condition at the conclusion of the procedure was reported to be fine and started total parental nutrition (tpn).

• Brand Name: WALLFLEX ¿ DUODENAL
• Type of Device: STENT,METALLIC,EXPANDABLE,DUODENAL
• 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: 7287511
• MDR Text Key: 100645501
• Report Number: 3005099803-2018-00461
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 08714729456490
• UDI-Public: 08714729456490
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2018

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
• Device Expiration Date: 11/21/2019
• Device Model Number: M00565020
• Device Catalogue Number: 6502
• Device Lot Number: 0021415432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/21/2018
• Supplement Dates Manufacturer Received: 03/04/2018; 04/13/2018
• Supplement Dates FDA Received: 03/29/2018; 05/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2017
• 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