MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM PILLCAM; SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE

Model Number FGS-0109

Device Problem Entrapment of Device (1212)

Patient Problems Abdominal Pain (1685); Vomiting (2144); Obstruction/Occlusion (2422); Radiation Exposure, Unintended (3164); Unintended Radiation Exposure (4565)

Event Date 07/03/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, a patient with crohn's disease, had an intact and stuck patency capsule 48 hours after ingestion.An x-ray showed an intact patency capsule and the patency capsule showed no signs of decay at the 30 hour mark and had created an obstruction of the stoma.The patient was admitted to the hospital, and the capsule was located and removed by scope.The capsule was predominantly intact, but the ends of it was black.The capsule was caught on a stricture close to the stoma.The computerized tomography (ct) scan highlighted more inflammation than what was expected, resulting in change to treatment of the patient's condition and dilation of the stricture was performed when the capsule was removed.The patient was not obese and has been discharged of the hospital.

Manufacturer Narrative

Additional information: b5, d10, g4, h3, h6.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, a patient with crohn's disease, had an intact and stuck patency capsule after ingestion.The patient developed abdominal pain and vomiting the next day.An abdominal x-ray was performed showing the capsule in the small bowel.28.5 hours after the capsule was swallowed, the patient stayed on clear fluids orally and waited to see if the capsule would break down.The patient then presented in the emergency department twice and had a further abdominal x-ray which was 58.5 hours post capsule ingestion, showed the capsule in the right lower quadrant adjacent to the stoma with no proximal intestinal dilatation.The patient went home the next day and received fluids, pain relief and anti-emetics for the symptoms.An x-ray showed an intact patency capsule and the patency capsule showed no signs of decay at the 30 hour mark and had created an obstruction of the stoma.The patient was admitted to the hospital, and the capsule was located and removed by scope.The capsule was predominantly intact, but the ends of it was black.The capsule was caught on a stricture close to the stoma.The computerized tomography (ct) scan highlighted more inflammation than what was expected, resulting in change to treatment such as ileoscopy and dilation of the stricture was performed when the capsule was removed.The patient was then commenced on steroid therapy and was discharged two days after.

Manufacturer Narrative

Additional information: b5, g4, h3, h6.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The patency capsule was received for evaluation.Visual in spection noted capsule didn't dissolve.It was reported that the capsule remained in the patient longer than expected.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: patients with suspected or known intestinal strictures may be at increased risk for bowel obstruction due to impaction of the intact patency capsule at the site of the narrowing or stricture, particularly during the first 1-2 days after capsule administration.Should this occur, patients may require bowel decompression until the capsule disintegrates or surgical intervention, if symptoms persist.Patients should be made aware of the signs and symptoms of bowel obstruction (abdominal pain, nausea, vomiting, and distention) and be advised to contact their physician should these symptoms occur anytime between capsule ingestion and documented excretion.Patients should also be informed that surgical intervention may be required if obstruction were to occur.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, a patient with crohn¿s disease had a patency capsule, but the patient developed abdominal pain and vomiting the next day.An abdominal x-ray was performed showing patency in the small bowel.The patient was on clear fluids orally 28.5 hours post ingestion and they waited to see if the capsule broke down as this would normally happen.The patient then presented at an emergency department twice two days after ingestion.First was at 58.5 hours post ingestion, an abdominal x-ray showed the capsule was in the right lower quadrant adjacent to the stoma with no proximal intestinal dilatation.Second was the third day post ingestion, the patient then received intravenous fluids, pain relief medications and anti-emetics, and was discharged the next day.Approximately 4 days post procedure, a computed tomography (ct) scan confirmed an active crohn¿s over a moderate length from the stoma distally and a separate segment of inflammation proximally.The capsule was still present adjacent to the stoma, caught on a stricture, and was found to have mild biliary and pancreatic duct dilatation.The patient underwent an ileoscopy, retrieval of the patency capsule and stoma dilatation.The patency capsule was still predominantly intact, but the ends of the capsule were black.They started the patient on steriod and enzyme replacement therapy and was discharged two days later from the hospital.A capsule endoscopy was not performed.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted there was a patient device interaction issue.The capsule did not dissolve.It was reported that the capsule remained in the patient longer than expected.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: patients with suspected or known intestinal strictures may be at increased risk for bowel obstruction due to impaction of the intact patency capsule at the site of the narrowing or stricture, particularly during the first 1-2 days after capsule administration.Should this occur, patients may require bowel decompression until the capsule disintegrates or surgical intervention, if symptoms persist.Patients should be made aware of the signs and symptoms of bowel obstruction (abdominal pain, nausea, vomiting, and distention) and be advised to contact their physician should these symptoms occur anytime between capsule ingestion and documented excretion.Patients should also be informed that surgical intervention may be required if obstruction were to occur.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PILLCAM
• Type of Device: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 10316967
• MDR Text Key: 200194064
• Report Number: 9710107-2020-00315
• Device Sequence Number: 1
• Product Code: NEZ
• UDI-Device Identifier: 07290101360629
• UDI-Public: 07290101360629
• Combination Product (y/n): N
• PMA/PMN Number: K090557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/07/2021

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: 10/27/2020
• Device Model Number: FGS-0109
• Device Catalogue Number: FGS-0109
• Device Lot Number: 48178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 08/19/2020; 10/06/2020; 03/17/2021
• Supplement Dates FDA Received: 09/04/2020; 10/09/2020; 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 81