MAUDE Adverse Event Report: COOK ENDOSCOPY UNKNOWN; ESW, PROSTHESIS, ESOPHAGEAL

Catalog Number UNKNOWN

Device Problem Migration or Expulsion of Device (1395)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Farks, p.S., farkas, j.D., koenigs, k.P.(1999), an easier method to remove migrated esophageal z-stents.American society for gastrointestinal endoscopy, 50:2, 277-279.Doi:https://doi.Org/10.1016/s0016-5107(99)70241-5.Date of event: 1999.Investigation evaluation: the investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report with further information.(b)(4).

Event Description

During an endoscopy, the physician used a cook esophageal z-stent [all registered part numbers now obsolete], as described in the below excerpts of a case report."a (b)(6)-year-old woman with a history of total esophagectomy for a proximal squamous cell carcinoma presented 4 months after surgery with dysphagia.An upper gastrointestinal x-ray series showed an apparently benign stricture at the anastomotic site.Computed tomography (ct) failed to demonstrate any signs of malignancy, and an endoscopy revealed a smooth stricture at the anastomosis 2.5 cm distal to the crico-pharyngeus.The stricture was dilated with savary dilators (wilson-cook, inc., (b)(6)) to 50f and brushed for cytology, which was benign.Although she did have temporary relief, the dysphagia returned.Over the next 4 months she underwent dilation several times, each time with only temporary relief of dysphagia, until a repeat ct demonstrated a tumor that was externally compressing the anastomosis.After attempts at treatment with radiation and chemotherapy failed, she was referred for stent placement.At upper endoscopy, the stricture was dilated to 40f, permitting the successful placement of a z-stent (wilson cook, (b)(6)).She had dramatic improvement in the dysphagia but this lasted only 24 hours, at which point a barium swallow demonstrated that the stent had migrated into her stomach (subject of this report).Upper endoscopy was undertaken to remove and replace the stent.The stricture was again encountered and dilated to 44f.A double-channel upper endoscope was passed through the stricture and the stent was visualized in the intrathoracic stomach.The stent could be grasped with a snare, but upon applying tension the snare would slip off the stent.Removal using either biopsy or rat-tooth forceps was unsuccessful because the stent would catch on the stricture.Our technique for removal of the stent utilized both a biopsy forceps (a rat-tooth forceps would probably have been better) and a snare.This technique requires passage of a double-channel therapeutic endoscope.In our case we found that savary dilation was required to pass the endoscope through the stricture.Once the stent is located, a snare is passed through one accessory channel of the endoscope.A biopsy or rat-tooth forceps is passed through the other channel.The snare is opened and the forceps is passed through the snare.The forceps is used to grasp the end of the stent.The snare is opened and advanced along the forceps and attached stent until it is around the proximal segment of the stent.The snare is then closed.This allows the stent to be firmly grasped and creates a tapering of the proximal stent that prevents the stent from catching on the esophagus.The endoscope, with both forceps and snare held securely, is withdrawn.With this method the stent was readily removed (subject of this report).Another stent was placed, which did not migrate.The procedure was well tolerated and without complication.The patient had no further dysphagia and died 2 months later [unrelated to removal of migrated stent]." a section of the device did not remain in the patient's body.The stent was removed.Via the method explained in the case report.Another stent was placed, which did not migrate.The procedure was well tolerated and without complication.The patient had no further dysphagia and died two (2) months later, unrelated to removal of the migrated esophageal stent.

Manufacturer Narrative

Farks, p.S., farkas, j.D., koenigs, k.P.(1999), an easier method to remove migrated esophageal z-stents.American society for gastrointestinal endoscopy, 50:2, 277-279.Doi:https://doi.Org/10.1016/s0016-5107(99)70241-5 continued from date of event: (b)(6)1999.Continued from event and problem and evaluation codes: method code- (b)(4).Continued from event and problem and evaluation codes: results code- (b)(4).Continued from event and problem and evaluation codes: conclusion code- 4315 cause not established; 11- conclusion not yet available-evaluation in progress is no longer applicable.Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.Cook endoscopy esophageal z-stents were obsolete in 2003.Prior to distribution, all esophageal z-stents were subjected to a visual inspection to ensure device integrity corrective action: corrective action is not warranted at this time because cook endoscopy esophageal z-stents were obsoleted in 2003 and all distributed devices are beyond their expected life span.A review of the complaint history was conducted and this represents an isolated occurrence.Quality assurance will continue to monitor for complaint trends.

Event Description

During an endoscopy, the physician used a cook esophageal z-stent [all registered part numbers now obsolete], as described in the below excerpts of a case report."a 67-year-old woman with a history of total esophagectomy for a proximal squamous cell carcinoma presented 4 months after surgery with dysphagia.An upper gastrointestinal x-ray series showed an apparently benign stricture at the anastomotic site.Computed tomography (ct) failed to demonstrate any signs of malignancy, and an endoscopy revealed a smooth stricture at the anastomosis 2.5 cm distal to the crico-pharyngeus.The stricture was dilated with savary dilators (wilson-cook, inc., winston-salem, n.C.) to 50f and brushed for cytology, which was benign.Although she did have temporary relief, the dysphagia returned.Over the next 4 months she underwent dilation several times, each time with only temporary relief of dysphagia, until a repeat ct demonstrated a tumor that was externally compressing the anastomosis.After attempts at treatment with radiation and chemotherapy failed, she was referred for stent placement.At upper endoscopy, the stricture was dilated to 40f, permitting the successful placement of a z-stent (wilson cook, winston-salem, n.C.).She had dramatic improvement in the dysphagia but this lasted only 24 hours, at which point a barium swallow demonstrated that the stent had migrated into her stomach (subject of this report).Upper endoscopy was undertaken to remove and replace the stent.The stricture was again encountered and dilated to 44f.A double-channel upper endoscope was passed through the stricture and the stent was visualized in the intrathoracic stomach.The stent could be grasped with a snare, but upon applying tension the snare would slip off the stent.Removal using either biopsy or rat-tooth forceps was unsuccessful because the stent would catch on the stricture.Our technique for removal of the stent utilized both a biopsy forceps (a rat-tooth forceps would probably have been better) and a snare.This technique requires passage of a double-channel therapeutic endoscope.In our case we found that savary dilation was required to pass the endoscope through the stricture.Once the stent is located, a snare is passed through one accessory channel of the endoscope.A biopsy or rat-tooth forceps is passed through the other channel.The snare is opened and the forceps is passed through the snare.The forceps is used to grasp the end of the stent.The snare is opened and advanced along the forceps and attached stent until it is around the proximal segment of the stent.The snare is then closed.This allows the stent to be firmly grasped and creates a tapering of the proximal stent that prevents the stent from catching on the esophagus.The endoscope, with both forceps and snare held securely, is withdrawn.With this method the stent was readily removed (subject of this report).Another stent was placed, which did not migrate.The procedure was well tolerated and without complication.The patient had no further dysphagia and died 2 months later [unrelated to removal of migrated stent]." a section of the device did not remain in the patient's body.The stent was removed.Via the method explained in the case report.Another stent was placed, which did not migrate.The procedure was well tolerated and without complication.The patient had no further dysphagia and died two (2) months later, unrelated to removal of the migrated esophageal stent.

• Brand Name: UNKNOWN
• Type of Device: ESW, PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7878263
• MDR Text Key: 120380436
• Report Number: 1037905-2018-00421
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• PMA/PMN Number: K920218
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 08/22/2018

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/22/2018
• Initial Date FDA Received: 09/14/2018
• Supplement Dates Manufacturer Received: 08/22/2018
• Supplement Dates FDA Received: 10/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE, UNKNOWN MAKE OR MODEL
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR