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

Catalog Number	1012531-60
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001.The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the non-calcified, mildly tortuous right external iliac artery.The 9x60mm absolute pro stent [self-expanding stent system (sess)] kinked, and the stent [sess] was unable to be removed.An unspecified balloon dilatation catheter was used to fracture [separate] the stent.An unspecified stent was used in the separated stent.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.
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 device was not returned for evaluation.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 incidents.The investigation determined that the reported difficulties and additional treatment appear to be due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: codes 2889, 1528, and 1562 were removed.
Event or Problem Description
Subsequent to the initially filed report, the following information was received: it was reported that the 9x60mm absolute pro self-expanding stent system (sess) was advanced without resistance, and the stent was implanted.The sess was removed without resistance.Due to the vessel tortuosity, the stent was kinked, which did not allow an unspecified balloon to cross.The unspecified guide wire already in the patient anatomy was passed through one of the stent struts, and the same balloon was used to dilate the stent through one of the stent struts.The stent did not break or separate, and an unspecified stent was placed in the previously deployed stent.No additional information was provided.

• 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: 9465673
• Report Number: 2024168-2019-14492
• Device Sequence Number: 2146051
• Product Code: NIP
• UDI-Device Identifier: 08717648175794
• UDI-Public: 08717648175794
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/14/2020

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: 07/31/2022
• Device Catalogue Number: 1012531-60
• Device Lot Number: 9080861
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 12/26/2019
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 01/14/2020
• 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
• Patient Age: 64 YR
• Patient Weight: 80