MAUDE Adverse Event Report: OBSIDIO, INC. OBSIDIO; VASCULAR EMBOLIZATION DEVICE

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

Patient Problems Ischemia (1942); Necrosis (1971); Pain (1994); Urinary Retention (2119); Bowel Perforation (2668); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/16/2023

Event Type  Injury  

Manufacturer Narrative

A2: age at time of event: 18 years or older h6: patient codes: appropriate term / code not available is listed for post embolization syndrome (pes).

Event Description

It was reported that patient complications occurred requiring hospitalization and patient expired.Obsidio was selected for a hemorrhoidal artery embolization of the bilateral superior and middle rectal arteries in all 4 branches.The size of the vessels were less than 2mm.The physician described variable feel of delivering obsidio in each of the arteries using the aliquot technique.The physician reported a total obsidio volume for entire procedure of around 0.25 ml.The physician did not notice any evidence of fragmentation on fluoroscopy.The patient was discharged home post procedure.The patient was readmitted to the hospital due to urinary retention.Leukocytosis was noted which felt secondary to the expected post-embolization syndrome.The patient had no significant rectal pain.A proctoscopy was performed at approximately 3 weeks into the admission.The patient was found to have approximately 25 cm long of circumferential necrosis of rectum consistent with ischemic changes.Pain at this point was improved and the patient was tolerating a full diet.Rescoping was performed 4-5 days later and ischemic changes appeared improved and the patient was discharged home.One week later, the patient was not feeling well and was readmitted to the hospital.A rectal perforation with focal 1 cm defect was noted.The patient underwent a diverting colostomy.The patient was never extubated post operatively and expired 5 weeks post procedure.

Event Description

It was reported that patient complications occurred requiring hospitalization and patient expired.Obsidio was selected for a hemorrhoidal artery embolization of the bilateral superior and middle rectal arteries in all 4 branches.The size of the vessels were less than 2mm.The physician described variable feel of delivering obsidio in each of the arteries using the aliquot technique.The physician reported a total obsidio volume for entire procedure of around 0.25 ml.The physician did not notice any evidence of fragmentation on fluoroscopy.The patient was discharged home post procedure.The patient was readmitted to the hospital due to urinary retention.Leukocytosis was noted which felt secondary to the expected post-embolization syndrome.The patient had no significant rectal pain.A proctoscopy was performed at approximately 3 weeks into the admission.The patient was found to have approximately 25 cm long of circumferential necrosis of rectum consistent with ischemic changes.Pain at this point was improved and the patient was tolerating a full diet.Rescoping was performed 4-5 days later and ischemic changes appeared improved and the patient was discharged home.One week later, the patient was not feeling well and was readmitted to the hospital.A rectal perforation with focal 1 cm defect was noted.The patient underwent a diverting colostomy.The patient was never extubated post operatively and expired 5 weeks post procedure.It was further reported per medical review with the treating physician, that the patient death is assessed as related to patient's underlying medical condition and is not directly related to the obsidio product.

Manufacturer Narrative

H6: patient codes: appropriate term / code not available is listed for post embolization syndrome (pes).B2: outcomes attrib to adv event: removed death b5: describe event or problem: additional information d4: updated unique identifier (udi) # from (b)(4).H6: impact codes: removed death code.H6: evaluation conclusion codes (1) updated from cmc-no problem detected to unintended use error caused or contributed to event.

• Brand Name: OBSIDIO
• Type of Device: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): OBSIDIO, INC.; 2 scimed pl; maple grove 55331
• Manufacturer (Section G): OBSIDIO; 2 scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18487080
• MDR Text Key: 332577835
• Report Number: 2124215-2023-75806
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Death
• Patient Age: 85 YR
• Patient Sex: Male