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

Model Number	IMP-10
Medical Device Problem Codes	Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Patient presented with a lusorian artery aneurysm.After deploying an abbot avpii plug to the aneurysm, an imp-10 was delivered using a 7fr terumo destination sheath.Five minutes after deployment, it was found the imp-10 anchor coil had elongated which motivated the physicians to remove the device by snaring it to prevent the possibility of migration occurring.Snaring the imp-10 caused the foam plug portion of the device to separate from the anchor coil and migrate towards the axillary artery.Ultimately, the physicians succeeded in removing the imp-10 radiopaque marker and much of the anchor coil and an estimated 80% of the foam plug.No adverse event to the patient occurred.Following this, the case was completed using a combination of imp-fx-12 and imp-fx-12x5 devices as well as other embolic devices not manufactured by smm.The patient status was reported stable.
Additional Manufacturer Narrative
Following delivery of an imp-10 device to treat a lusorian artery aneurysm, the anchor coil of the device had elongated which motivated the physicians to remove the device by snaring it to prevent the possibility of migration from occurring.Snaring led the foam plug portion of the imp-10 device to separate from the anchor coil and migrate towards the axillary artery.The physicians removed the imp-10 radiopaque marker, the majority of the anchor coil, and an estimated 80% of the foam plug.No adverse event resulted from the device malfunction.This device has been returned to shape memory medical and a supplemental report will be filed after the investigation is completed.
Additional Manufacturer Narrative
Five minutes after the physician deployed the imp-10 device to the lusorian artery aneurysm, the imp-10 coil had straightened.Because of this, the physician chose to snare the imp-10 device so as to prevent the possibility of migration occurring.Snaring the device caused the foam plug portion of the device to separate from the anchor coil and migrate towards the axillary artery.Note: snaring is not recommended per the impede ifu.The ifu only advises device withdrawal "if difficulties occur when deployed the impede embolization plug and the smp plug has not exited the cathter/sheath within the recommended working time." under these circumstances, the physician is advised to "wait a minimum of five (5) minutes to allow the smp plug to expand within the catheter/sheath.Withdraw and remove the guidewire; using a syringe to apply light suction, remove the device and catheter/sheath simultaneously as one unit." shape memory medical's investigation of this incident comprised of record review, inspection of the returned imp-10 components, and review of images and videos provided from the case.Record review did not identify any findings that could be related to the reported anchor coil elongation.Inspection of the returned imp-10 foam plug component confirmed that the entirety of the foam plug was not removed from the patient.Additionally, the anchor coil (which consists of a platinum coil bonded to a nitinol core wire) appeared to be made to specification, however, it was found that it was found that the weld bonding the platinum coil to the nitinol wire had failed.This likely occurred during device snaring.Finally, images and videos of the device delivery provided from the case were reviewed.Based on the information known about this incident, no definitive root cause can be attributed to the anchor coil elongation.It is possible that due to anatomical variation the anchor coil may deploy in different configurations (including straight).
Event or Problem Description
Patient presented with a lusorian artery aneurysm.After deploying an abbot avpii plug to the aneurysm, an imp-10 wasdelivered using a 7fr terumo destination sheath.Five minutes after deployment, it was found the imp-10 anchor coil had elongated which motivated the physicians to remove the device by snaring it to prevent the possibility of migration occurring.Snaring the imp-10 caused the foam plug portion of the device to separate from the anchor coil and migrate towards the axillary artery.Ultimately, the physicians succeeded in removing the imp-10 radiopaque marker and much of the anchor coil and anestimated 80% of the foam plug.No adverse event to the patient occurred.Following this, the case was completed using a combination of imp-fx-12 and imp-fx-12x5 devices as well as other embolic devices not manufactured by smm.The patient status was reported stable.

• 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 ; 4086495175
• MDR Report Key: 15157566
• Report Number: 3013353964-2022-00002
• Device Sequence Number: 5323890
• Product Code: KRD
• UDI-Device Identifier: 00810041650023
• UDI-Public: +00810041650023
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2024
• Device Model Number: IMP-10
• Device Catalogue Number: IMP-10
• Device Lot Number: F22051301E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2022
• 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
• Patient Sex: Unknown