MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO VASCULAR; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number	1012536-40
Medical Device Problem Codes	Material Separation (1562); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Na.
Event or Problem Description
It was reported the procedure was performed on (b)(6) 2019 to treat a lesion in the 60% stenosed pulmonary vein.The 8.0x40mm absolute pro stent was deployed in the lesion however the stent did not appear to be fully apposed to the vessel wall.On (b)(6) 2019, an attempt was made to remove the deployed stent with a snare device however the stent separated.All parts of the stent were retrieved and removed from the patient.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional analysis was performed on the returned device.The reported stent separation was confirmed.The reported stent apposition could not be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents.The investigation determined that the difficulties and subsequent treatment appear to be related to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Correction: expiration date.

• Brand Name: ABSOLUTE PRO VASCULAR
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8826366
• Report Number: 2024168-2019-10351
• Device Sequence Number: 18909745
• Product Code: NIP
• UDI-Device Identifier: 08717648176142
• UDI-Public: 08717648176142
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 1012536-40
• Device Lot Number: 6092662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 10/14/2019
• 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: Hospitalization; Required Intervention