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

Catalog Number	1012538-100
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Patient-Device Incompatibility (2682); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
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.It is unknown if the device is returning for analysis.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 external iliac artery.A 10x100mm absolute pro self-expanding stent system (sess) was being deployed; however, about half way through deployment the thumb wheel was no longer able to move.Something finally snapped and the stent came off in the patient.The deployed stent was trapped with another unspecified absolute pro stent.The patient is doing well.There was no adverse patient sequela.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 evaluation.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the lot number was not reported.The investigation determined that the reported difficulties appear to be due to operational context of the procedure.The resistance advancing was due to the tight aortic arch.Additionally, it is likely that advancing the absolute pro over the tight arch caused the shaft to kink or bend such that the shaft lumens were unable to move freely resulting in resistance with the thumbwheel and partial stent deployment.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The received by manufacturer date on initial should have been 11/1/2019.
Event or Problem Description
Additional information: after the thumb wheel could no longer move, force was applied and the 10x100mm absolute pro stent released.The deployed stent was not fully apposed; therefore, a second stent was used to fully deploy the stent and trap it in its location and fully deploy it.There was no clinically significant delay in the procedure.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: 9369385
• Report Number: 2024168-2019-13851
• Device Sequence Number: 14002581
• Product Code: NIP
• UDI-Device Identifier: 08717648176319
• UDI-Public: 08717648176319
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 12/23/2019

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 Catalogue Number: 1012538-100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/03/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 12/23/2019
• 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: Required Intervention