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

Catalog Number	1012534-40
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional absolute pro vascular device is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified lesion in the popliteal artery and both stents prematurely deployed.The absolute pro vascular 6.0x40 mm deployed in the superficial femoral artery and the absolute pro vascular 6.0x60 mm deployed in the iliac artery.The stents were left where they were deployed, which was also diseased tissue.A new stent was used to treat the target lesion.There was no reported resistance during advancement.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
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.The device was not returned for analysis.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 of the reported lot revealed no other similar incidents.The investigation determined that the reported difficulties were related to case circumstances.It is likely that the distal sheath of the absolute pro delivery system interacted with the calcified vessel in the popliteal artery such that the sheath was pulled back or kinked resulting in the partial deployment.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 9417357
• Report Number: 2024168-2019-14165
• Device Sequence Number: 448393
• Product Code: NIP
• UDI-Device Identifier: 08717648175985
• UDI-Public: 08717648175985
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 1012534-40
• Device Lot Number: 9061161
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 01/03/2020
• 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: Other
• Patient Age: 86 YR