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

Model Number	IMP-10
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The impede embolization plug was used to treat pelvic congestion syndrome.Review of the lot history record and accompanying lot release test report identified no quality issues related to device performance.The plug was unable to be returned as it was implanted in the patient.Further, the chosen plug size was outside the recommended vessel diameter range per the impede ifu.A definitive root cause cannot be established at this time based off of the information provided by the complainant.A supplemental report will be filed should additional information be received from the complainant.
Event or Problem Description
On (b)(6) 2021, the physician delivered an imp-10 to the left ovarian vein (11 mm in diameter) to treat pelvic congestion syndrome.After waiting 10 minutes and observing no vessel occlusion, the physician then completed the case by injecting sclerosant distal to the site where the plug was delivered.

• 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
• MDR Report Key: 11950532
• Report Number: 3013353964-2021-00001
• Device Sequence Number: 3965270
• Product Code: KRD
• UDI-Device Identifier: 00810041650023
• UDI-Public: 00810041650023
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2021

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: 08/28/2021
• Device Model Number: IMP-10
• Device Catalogue Number: IMP-10
• Device Lot Number: F19081201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1