MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX¿ ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL

Model Number M00516240

Device Problem Material Integrity Problem (2978)

Patient Problem Unspecified Infection (1930)

Event Date 11/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported to boston scientific corporation on december 05, 2016, that a wallflex esophageal fully covered rmv stent was implanted in the esophagus to treat a post-surgical esophageal leak during a stent placement procedure performed on (b)(6) 2016.According to the complainant, one day after stent placement, a "micro leak" was noted at the site of stent placement.The physician endoscopically examined the stent the next day, but could not find any leakage.The physician placed a second stent across the suspected leakage location.On (b)(6) 2016, the complainant reported to boston scientific corporation that the wallflex esophageal fully covered rmv stent had a tear or hole in the stent cover, that the patient had undergone subsequent surgical procedures, developed a persistent lung infection, and that the patient's hospital stay had been extended.It was also reported that the leak at the stent site was confirmed via barium swallow imaging and that the wallflex esophageal fully covered rmv stent was removed from the patent on an unknown date.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Note: the wallflex esophageal fully covered rmv stent is indicated to treat benign and malignant strictures and is not indicated to treat post-surgical esophageal leaks.

Manufacturer Narrative

Additional information received on january 12, 2017.One wallflex fully covered esophageal rmv stent was received for analysis.The delivery system was not returned.A visual evaluation of the stent noted a ridge in the stent cover approximately 1 cm proximal to the distal flare, which is an artifact of manufacturing and is within the device specifications.While the stent was in a neutral position, there were no visible pinholes or tears in the cover.When the stent was pinched around the ridge, two openings in the covering were visible at the point of the ridge, however these openings measured less than 1 mm across, which is within specification.There were no other issues noted with the stent.A labeling review was performed and, from the information available, there is evidence that the device was not used per the directions for use (dfu) / product label.The dfu states ¿the wallflex esophageal fully covered rmv stent system is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, occlusion of concurrent esophageal fistulas and treating refractory benign esophageal strictures.¿ the dfu also lists the following as contraindications: ¿any use other than those specifically outlined under indications for use,¿ and ¿placement in an esophago-jejunostomy (following gastrectomy), as peristalsis and altered anatomy may displace stent.¿ however, it was reported that the stent was used to treat a post-surgical esophageal leak in a patient who had undergone an esophagojejunostomy.The investigation concluded that this complaint is associated with a product that meets specification however the user is dissatisfied with the function, performance or appearance of the product.Therefore, the most probable root cause classification is user preference issue.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 confirmed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation on december 05, 2016, that a wallflex esophageal fully covered rmv stent was implanted in the esophagus to treat a post-surgical esophageal leak during a stent placement procedure performed on (b)(6) 2016.According to the complainant, one day after stent placement, a "micro leak" was noted at the site of stent placement.The physician endoscopically examined the stent the next day, but could not find any leakage.The physician placed a second stent across the suspected leakage location.On (b)(6) 2016, the complainant reported to boston scientific corporation that the wallflex esophageal fully covered rmv stent had a tear or hole in the stent cover, that the patient had undergone subsequent surgical procedures, developed a persistent lung infection, and that the patient's hospital stay had been extended.It was also reported that the leak at the stent site was confirmed via barium swallow imaging and that the wallflex esophageal fully covered rmv stent was removed from the patent on an unknown date.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Note: the wallflex esophageal fully covered rmv stent is indicated to treat benign and malignant strictures and is not indicated to treat post-surgical esophageal leaks.Additional information received on january 12, 2017: according to the complainant, the cause of the patient's underlying esophageal leak was ischaemia with previous radiotherapy.Reportedly, prior to implantation of the wallflex esophageal fully covered rmv stent, the patient underwent an esophagojejunal anastomosis.The patient's esophageal leak was noted within 2 days post-op.The first wallflex esophageal fully covered rmv stent was implanted on (b)(6) 2016 (not (b)(6) 2016, as previously reported).The stent was positioned such that the patient's esophageal perforation was covered completely by the stent, with 4 cm of coverage on either side.The leak at the site of stent placement was noted on (b)(6) 2016.The second stent was implanted on (b)(6) 2016.A fluoroscopic examination revealed that there was still a leak at the first stent, so the second stent was repositioned into the first stent, which stopped the leak.However, another leak was then noted t the site of the patient's esophagojejunal anastomosis, so both stents were removed from the patient on (b)(6) 2016, and the patient taken to surgery.During this surgery, the patient's esophagojejunal anastomosis was disconnected.The patient is currently recovering but will require surgery in 4-6 months to reconnect the esophagojejunal anastomosis.Presently, the patient's open wound is healing with a vacuum dressing.The patient has a nasogastric draining tube in place and is on total enteral feeding via a jejunostomy feeding tube.The patient's infection is being controlled with longterm antibiotics, drains, and daily lavage.

Event Description

It was reported to boston scientific corporation on (b)(6) 2016, that a wallflex esophageal fully covered rmv stent was implanted in the esophagus to treat a post-surgical esophageal leak during a stent placement procedure performed on (b)(6) 2016.According to the complainant, one day after stent placement, a "micro leak" was noted at the site of stent placement.The physician endoscopically examined the stent the next day, but could not find any leakage.The physician placed a second stent across the suspected leakage location.On (b)(6) 2016, the complainant reported to boston scientific corporation that the wallflex esophageal fully covered rmv stent had a tear or hole in the stent cover, that the patient had undergone subsequent surgical procedures, developed a persistent lung infection, and that the patient's hospital stay had been extended.It was also reported that the leak at the stent site was confirmed via barium swallow imaging and that the wallflex esophageal fully covered rmv stent was removed from the patent on an unknown date.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Note: the wallflex esophageal fully covered rmv stent is indicated to treat benign and malignant strictures and is not indicated to treat post-surgical esophageal leaks.Additional information received on january 12, 2017: according to the complainant, the cause of the patient's underlying esophageal leak was ischaemia with previous radiotherapy.Reportedly, prior to implantation of the wallflex esophageal fully covered rmv stent, the patient underwent an esophagojejunal anastomosis.The patient's esophageal leak was noted within 2 days post-op.The first wallflex esophageal fully covered rmv stent was implanted on (b)(6) 2016 (not (b)(6) 2016, as previously reported).The stent was positioned such that the patient's esophageal perforation was covered completely by the stent, with 4 cm of coverage on either side.The leak at the site of stent placement was noted on (b)(6) 2016.The second stent was implanted on (b)(6) 2016.A fluoroscopic examination revealed that there was still a leak at the first stent, so the second stent was repositioned into the first stent, which stopped the leak.However, another leak was then noted at the site of the patient's esophagojejunal anastomosis, so both stents were removed from the patient on (b)(6) 2016, and the patient was taken to surgery.During this surgery, the patient's esophagojejunal anastomosis was disconnected.The patient is currently recovering but will require surgery in 4-6 months to reconnect the esophagojejunal anastomosis.Presently, the patient's open wound is healing with a vacuum dressing.The patient has a nasogastric draining tube in place and is on total enteral feeding via a jejunostomy feeding tube.The patient's infection is being controlled with longterm antibiotics, drains, and daily lavage.Additional information received on february 08, 2017: the complainant reported that the patient underwent a gastroscopy on (b)(6) 2016, which revealed a 1 cm esophageal perforation at 38 cm just above the patient's esophageal anastomosis.Under fluoroscopic imaging, the 10 cm wallflex esophageal fully covered rmv stent was deployed over the perforation with 4 cm of coverage proximally and 5 cm of coverage distally.The stent placement was uneventful, and the perforation was visibly covered by the stent on endoscopic imaging.The patient had a left chest drain placed just lateral to the perforation.2 days after the stent placement, it was noted that the output from this drain remained at greater than 1 liter per day.On (b)(6) 2016, the patient underwent a repeat gastrograffin study, during which a leak was identified within the stent with the contrast transversing to the left and into the chest drain.The patient was taken to the operating theater and, under general anesthesia, fluoroscopic imaging was undertaken.With the patient under general anesthesia, the physician was unable to reproduce the stent leak, and a gastroscopy showed that the stent had not moved and was covering the perforation.It was noted that there appeared to be a small amount of reflux at the distal end of the stent.A second stent was placed within the first stent covering 50% of this, and the end of the second stent was therefore passing distally into the jejunum.On (b)(6) 2016, aspiration of the left chest drain was performed and 250 ml of light bile-type fluid was drained.A repeat fluoroscopy demonstrated the same stent leak that was identified during the imaging on (b)(6) 2016.The distal second stent was pulled back into the first stent, which then covered the stent leak.However, after placing the second stent into the first stent, the fluoroscopy assessment showed that the esophagojejunal anastomosis had been disrupted with a dehiscence on the posterior wall of the anastomosis.The patient was taken to the operating theater and both stent were retrieved endoscopically and it was noted that the anastomosis had disrupted posteriorly with a gap of 2 cm.The physician disconnected the esophagus with transection due to the presence of infection and leakage.A feeding jejunostomy was inserted into the patient¿s proximal jejunum to provide completed enteral feeding, and the patient¿s chest and abdominal sepsis was controlled with multiple drains and several types of antibiotics.The patient later developed wound infection with abdominal wound dehiscence, and underwent vacuum-assisted closure (vac) dressing therapy on (b)(6) 2016.On (b)(6) 2016, the patient developed feculent material in the open would which was found to be due to a mid-transverse colon fistula.On (b)(6) 2016, the patient underwent a defunctioning colostomy at the hepatic flexure.The patient's chest sepsis was controlled and the patient was discharged home on (b)(6) 2017 with a small amount of purulent discharge which had grown pseudomonas.The patient remains on ciprofloxacin and has a feeding jejunostomy, hiatal drain, ng tube to the esophageal stump, and vac dressing therapy.

• Brand Name: WALLFLEX¿ ESOPHAGEAL
• Type of Device: PROSTHESIS, ESOPHAGEAL
• 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: 6228505
• MDR Text Key: 64036780
• Report Number: 3005099803-2017-00025
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: SG
• PMA/PMN Number: SIMILAR
• 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,Followup
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2018
• Device Model Number: M00516240
• Device Catalogue Number: 1624
• Device Lot Number: 19582217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 64 YR