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

Catalog Number	1012532-40
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2019
Type of Reportable Event	Malfunction
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 is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.Na.
Event or Problem Description
It was reported that the procedure was performed to treat a de novo, eccentric lesion in the mildly tortuous, mildly calcified common iliac artery.After a non-abbott balloon was inflated once at eight atmospheres for 60 seconds, a 10x40mm absolute pro vascular self-expanding stent system (sess) was advanced and the stent was deployed.The proximal marker of the absolute pro sess became stuck with a non-abbott introducer sheath during removal.The device was removed together with the sheath as a single unit.The sess was unable to be removed from the sheath despite intentional manipulation outside the anatomy.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional analysis was performed on the returned device.The reported difficulty removing was confirmed as slight resistance was noted during removal.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 was unable to determine a cause for the reported difficulty.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.Correction: device manufacturing 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: 8809485
• Report Number: 2024168-2019-10210
• Device Sequence Number: 13534876
• Product Code: NIP
• UDI-Device Identifier: 08717648175848
• UDI-Public: 08717648175848
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 1012532-40
• Device Lot Number: 8050861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GOODTECH Y CONNECTOR; MEDIKIT 6F SHEATH 11 CM; TREASURE FLOPPY GW