MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA; PTK PEDIATRIC ESOPHAGEAL ATRESIA ANASTOMOSIS DEVICE

Model Number	G47283
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Stenosis of the esophagus (4487)
Type of Reportable Event	Serious Injury
Event or Problem Description
A pediatric patient with pre-existing esophageal atresia underwent placement of a cook flourish pediatric esophageal atresia device.The subject had type a esophageal atresia.The initial untreated gap measurement was 5.5 cm.At 120 days from birth, the patient underwent thoroscopic mobilization of upper pouch, scharli operation to mobilize distal esophageal pouch and proximal stomach into thorax, right thoracotomy, and pyloromyotomy.During the same procedure, the flourish¿ pediatric esophageal atresia device was placed with the patient under general anesthesia.The length of the resulting esophageal gap was 3 cm.The lower flourish device was repositioned under fluoroscopy at 1 day post-placement, and at 4 days post-placement.Eleven days after placement (131 days of age), anastomosis was achieved, as evidenced by connected flow of contrast agent on esophagram, and the flourish magnets were removed.The first dilation of stricture at the anastomotic site occurred 36 days following device removal.The patient underwent subsequent dilation 49, 61, 74, 91, 98, 112 (+ steroid injection), 133 (+ steroid injection), 158, 180, 207 (+ stent placement, with stent removal at 250 days post-flourish removal), 410, and 729 days following flourish removal.At 524 days and 729 days post-flourish removal, the patient had emergency esophagoscopy for food impaction.The subject of this report is the stricture treatment.
Additional Manufacturer Narrative
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.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: the report indicated the patient was treated for stricture at the anastomotic site.The ifu states the following: "based on limited clinical data on this device, the rate of endoscopic dilation or surgical intervention for stenosis of the anastomosis is higher than that following surgery." prior to distribution, all flourish pediatric esophageal atresia devices are subjected to a visual inspection and functional testing to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
Event or Problem Description
The following was originally reported: "a pediatric patient with pre-existing esophageal atresia underwent placement of a cook flourish pediatric esophageal atresia device.The subject had type a esophageal atresia.The initial untreated gap measurement was 5.5 cm.At 120 days from birth, the patient underwent thoroscopic mobilization of upper pouch, scharli operation to mobilize distal esophageal pouch and proximal stomach into thorax, right thoracotomy, and pyloromyotomy.During the same procedure, the flourish¿ pediatric esophageal atresia device was placed with the patient under general anesthesia.The length of the resulting esophageal gap was 3 cm.The lower flourish device was repositioned under fluoroscopy at 1 day post-placement, and at 4 days post-placement.Eleven days after placement (131 days of age), anastomosis was achieved, as evidenced by connected flow of contrast agent on esophagram, and the flourish magnets were removed.The first dilation of stricture at the anastomotic site occurred 36 days following device removal.The patient underwent subsequent dilation 49, 61, 74, 91, 98, 112 (+ steroid injection), 133 (+ steroid injection), 158, 180, 207 (+ stent placement, with stent removal at 250 days post-flourish removal), 410, and 729 days following flourish removal.At 524 days and 729 days post-flourish removal, the patient had emergency esophagoscopy for food impaction.The subject of this report is the stricture treatment." it was originally reported that the above dilations, injection, stent placement, and esophagoscopies were a number of days "post-removal" of the flourish.New information was received on 08/01/2023 from the user facility that clarified these dates should be "post-placement" of the flourish, not "post-removal" of flourish.

• Brand Name: FLOURISH PEDIATRIC ESOPHAGEAL ATRESIA
• Common Device Name: PTK PEDIATRIC ESOPHAGEAL ATRESIA ANASTOMOSIS DEVICE
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 16163983
• Report Number: 1037905-2023-00022
• Device Sequence Number: 17893885
• Product Code: PTK
• UDI-Device Identifier: 10827002472836
• UDI-Public: (01)10827002472836(17)200531(10)W4221406
• Combination Product (Y/N): N
• PMA/510(K) Number: H150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: G47283
• Device Catalogue Number: FLRSH-PEA
• Device Lot Number: W4221406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 5 KG