MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN CATHETER; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number UNKNOWN-C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Cyst(s) (1800); Abdominal Distention (2601)

Event Date 03/21/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Hong-cai wang, yi-lei tong, shi-wei li, mao-song chen, bo-ding wang and hai chen.Hemorrhagic abdominal pseudocyst following ventric uloperitoneal shunt: a case report.Bmc surgery 21 (2021).Doi: 10.1186/s12893-021-01161-y.Abstract background: abdominal cerebrospinal fluid (csf) pseudocyst is an uncommon but important complication of ventriculoperitoneal (vp) shunts.While individual articles have reported many cases of abdominal csf pseudocyst following vp shunts, no case of a hemorrhagic abdominal pseudocyst after vp shunts has been reported so far.Case presentation: this article reports a (b)(6) year-old woman with a 4-month history of progressive abdominal pain and distention.She denied any additional symptoms.A vp shunt was performed 15 years earlier to treat idiopathic normal pressure hydrocephalus and no other abdominal surgery was performed.Physical examination revealed an elastic palpable mass in her right lower abdomen, which was dull to percussion.Abdominal computed tomography (ct) scan indicated a large cystic collection of homogenous iso-density fluid in the right lower abdominal region with clear margins.The distal segment of the peritoneal shunt catheter was located within the cystic mass.Abdominal csf pseudocyst was highly suspected as a diagnosis.Laparoscopic cyst drainage with removal of the whole cystic mass was performed, 15-cm cyst which found with thick walls and organized chronic hematic content.No responsible vessel for the cyst hemorrhage was identified.No further shunt revision was placed.Histological examination showed that the cyst wall consisted of outer fibrous tissue and inner granulation tissue without epithelial lining, and the cystic content was chronic hematoma.The patient had an uneventful postoperative course and remained asymptomatic for 8-mo follow-up.Conclusion: to the best of our knowledge, this is the first report of hemorrhagic onset in the abdominal pseudocyst following vp shunt.Such special condition can accelerate the appearance of clinical signs of the abdominal pseudocyst after vp shunts, and its mechanisms may be similar to the evolution of subdural effusion into chronic subdural hematoma (csdh).Reported event: a (b)(6) year-old woman presented to the emergency department with a 4-month history of progressive abdominal pain and distention.She began with mild abdominal discomfort and did not care about it at first.Abdominal pain was then aggravated gradually to moderate level and restricted to the right lower abdominal region.She was awake and denied any additional symptoms such as headaches, nausea, vomiting, decreased appetite, constipation, fever, or chills.In addition, no neurological change was observed.A vp shunt with strata® (medtronic) programmable valve system was placed 15 years earlier to treat idiopathic normal pressure hydrocephalus and the valve pressure was 1.5.The patient had no history of abdominal blunt trauma, malignancy, pancreatic or liver diseases.No other abdominal surgery or shunt revision was performed.Physical examination revealed an elastic palpable mass in her right lower abdomen, which was dull to percussion.Her abdomen was minimally tender in the right lower abdominal quadrant, but no rigid or tense.No skin changes overlying her shunt catheter and no signs of intracranial hypertension were found.A lumbar puncture was performed to analyze csf.Csf pressure, nucleated cells and protein count were normal; culture of the csf was also negative for microorganisms.In addition, no evidence of infection was found on other laboratory examinations.Unenhanced abdominal computed tomography (ct) scan indicated a large cystic collection of homogenous iso-density fluid in the right lower abdominal region with clear margins.The distal segment of the peritoneal shunt catheter was located within the cystic mass.The cystic mass, independent from the abdominal viscera, was nonloculated and 25¿30 hounsfield units in attenuation.There was no colonic obstruction.Dilation of the ventricular system was found on the cerebral ct imaging and the evans ratio (er) value was 0.4.Although the ventricular system was enlarged, interstitial cerebral edema and hemorrhage in brain or along the catheter were not found.Moreover, the trajectory of the shunt on the skull and abdomen¿thorax x ray did not show the catheter breakage, disconnection or migration.Abdominal csf pseudocyst was highly suspected as a preoperative diagnosis.Laparoscopic cyst drainage with excision of the whole cyst was performed, 15-cm cyst which found with thick walls and organized chronic hematic content.The cyst was tense and had mild adhesions.More than 2 l of the hematoma fluid was drained off.The csf in the cyst or dripping from the end of shunt catheter was not found, and the shunt malfunction was diagnosed during operation.The distal side of peritoneal shunt catheter within the cyst was cut and then removed from her abdominal cavity.Responsible vessels associated with the cyst hemorrhage were not identified during operation and there was no definite feeding artery for the cyst.No further shunt revision was performed.A thick-walled capsule collecting hematoma fluid was further demonstrated post-surgical gross pathology specimen.Culture of the intracystic content was negative for microorganisms.Histological examination showed that the cyst wall consisted of outer fibrous tissue and inner granulation tissue without epithelial lining, and the cystic content was chronic hematoma.The patient had an uneventful postoperative course and remained asymptomatic for 8-mo follow-up.

• Brand Name: UNKNOWN CATHETER
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer Contact: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 12000999
• MDR Text Key: 262874359
• Report Number: 2021898-2021-00128
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-C
• Device Catalogue Number: UNKNOWN-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2021
• 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: 68 YR