MAUDE Adverse Event Report: ST. JUDE MEDICAL CATD AMPLATZER VASCULAR PLUG II; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	9-AVP2-012
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2019, a 10mm amplatzer vascular plug ii (avpii) was selected for implant.However, the device was mis-sized and did not occlude or partially occlude the defect.The avpii was recaptured and removed from the patient.A new 12mm avpii was then selected for implant.However, the 12mm avpii was also mis-sized and did not occlude or partially occlude the defect.The 12mm avpii was recaptured and removed from the patient.Then, the patient was transferred to the ctvs department.The case was abandoned due to the devices because the intended result to occlude the defect was not achieved.No patient consequences were reported.
Additional Manufacturer Narrative
An event of the device not occluding the defect was reported.The device met dimensional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the reported event could not be conclusively determined, however it is consistent with mis-sizing.
Event or Problem Description
On (b)(6) 2019, a 10mm amplatzer vascular plug ii (avpii) was selected for implant.However, the device was mis-sized and did not occlude or partially occlude the defect.The avpii was recaptured and removed from the patient.A new 12mm avpii was then selected for implant.However, the 12mm avpii was also mis-sized and did not occlude or partially occlude the defect.The 12mm avpii was recaptured and removed from the patient.Then, the patient was transferred to the ctvs department.The case was abandoned due to the devices because the intended result to occlude the defect was not achieved.No patient consequences were reported.

• Brand Name: AMPLATZER VASCULAR PLUG II
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 9397739
• Report Number: 2135147-2019-00371
• Device Sequence Number: 16597882
• Product Code: KRD
• UDI-Device Identifier: 00811806010397
• UDI-Public: 00811806010397
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K071125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

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: 01/31/2024
• Device Model Number: 9-AVP2-012
• Device Catalogue Number: 9-AVP2-012
• Device Lot Number: 6873499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 12/24/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention