MAUDE Adverse Event Report: SHAPE MEMORY MEDICAL INC. IMPEDE EMBOLIZATION PLUG; VASCULAR EMBOLIZATION DEVICE

Model Number	IMP-07
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The reported date of the event is (b)(6) 2021, although the initial procedure took place on (b)(6) 2021.On (b)(6) 2021, a 2-debranch tevar was being performed and an imp-10 and imp-07 was used to embolize the left subclavian artery (lsca) at the same time.The imp-10 was introduced into the body first, followed by the imp-07 in parallel; both devices were reported to be delivered into the target site.The operation was completed, although it was not confirmed at the time that embolization of the lsca was achieved with the imp-10 device.On (b)(6) 2021, during the post-operative examination using contrast-enhanced computed tomography, a type ii endoleak was found at the lsca.On (b)(6) 2021, an operation was performed to treat the type ii endoleak found during the post-operative examination using additional non-smm embolic coil devices (3 interlock coils from boston scientific).These devices were deployed to the lsca from the vicinity of the impede embolization plugs, using an impress 5fr diagnostic catheter from merit medical.It was confirmed that the interlock coils were delivered, complete embolization was achieved, the type ii endoleak had disappeared, and the operation was completed.This event did not result in any harm to the patient.
Additional Manufacturer Narrative
The impede embolization plug was used to treat the left subclavian artery during a 2-debranch tevar.A review of the lot history record and accompanying lot release report identified no quality issues related to device performance.A definitive root cause cannot be established at this time based off of the information provided by the complainant as well as that the plug was unable to be returned as it was implanted in the patient.
Additional Manufacturer Narrative
The original form 3500a that was submitted for mfr report #: 3013353964-2022-00001 mistakenly identified only one of the two suspected medical devices (i.E., imp-10) involved with this case.This form 3500a is being submitted as a correction to the original form 3500a to include the device information for the second suspected medical device (i.E., imp-07) associated with this case.
Event or Problem Description
The reported date of the event is 13-dec-2021, although the initial procedure took place on (b)(6) 2021.On (b)(6) 2021, a 2-debranch tevar was being performed and an imp-10 and imp-07 was used to embolize the left subclavian artery (lsca) at the same time.The imp-10 was introduced into the body first, followed by the imp-07 in parallel; both devices were reported to be delivered into the target site.The operation was completed, although it was not confirmed at the time that embolization of the lsca was achieved with both imp-10 & imp-07 devices.On (b)(6) 2021, during the post-operative examination using contrast-enhanced computed tomography, a type ii endoleak was found at the lsca.On (b)(6) 2021, an operation was performed to treat the type ii endoleak found during the post-operative examination using additional non-smm embolic coil devices (3 interlock coils from boston scientific).These devices were deployed to the lsca from the vicinity of the impede embolization plugs, using an impress 5fr diagnostic catheter from merit medical.It was confirmed that the interlock coils were delivered, complete embolization was achieved, the type ii endoleak had disappeared, and the operation was completed.This event did not result in any harm to the patient.

• Brand Name: IMPEDE EMBOLIZATION PLUG
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SHAPE MEMORY MEDICAL INC.; 807 aldo ave.; suite 109; santa clara CA 95054 2252
• Manufacturer (Section G): SHAPE MEMORY MEDICAL INC.; 807 aldo ave.; suite 109; santa clara CA 95054 2252
• Manufacturer Contact: meghan reu ; 807 aldo ave.; suite 109; santa clara, CA 95054-2252
• MDR Report Key: 13311458
• Report Number: 3013353964-2022-00001
• Device Sequence Number: 14685964
• Product Code: KRD
• UDI-Device Identifier: 00810041650016
• UDI-Public: 00810041650016
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

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
• Device Expiration Date: 12/20/2021
• Device Model Number: IMP-07
• Device Catalogue Number: IMP-10
• Device Lot Number: F19121201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2019
• 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: Hospitalization
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian