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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Necrosis (1971); Pain (1994); Urinary Retention (2119); Bowel Perforation (2668); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2124215-2023-75806
• Device Sequence Number: 3533979
• Product Code: KRD
• UDI-Device Identifier: 00191506043124
• UDI-Public: 00191506043124
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K213385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2024

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?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Death
• Patient Age: 85 YR
• Patient Sex: Male