MAUDE Adverse Event Report: AV-TEMECULA-CT ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number	1012530-100
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	08/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned.Visual inspection and functional inspection was performed on the returned device.The difficulties could not be replicated due to the condition of the returned device.It was noted that the outer member was separated at two locations (outer member was separated 1.3cm proximal to the proximal end of distal outer sheath and the inner braiding and the outer member was separated 2mm distal to the proximal end of the rack).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 incidents.The investigation determined that the reported difficulties and subsequent treatment were likely due to operational circumstances of the procedure.Kinks were noted on the distal sheath which suggest that the sheath was likely bent/restricted in the anatomy and caused restriction between the shaft lumens, resulting in difficulty rotating the thumbwheel and deployment failure due to the outer member separation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported the procedure was to treat a heavily calcified lesion in the right common iliac.The 8.0x100mm absolute pro vascular self expanding stent system (sess) was advanced with resistance noted due to the anatomy.During attempted deployment, the thumbslide failed to completely deploy the stent.Resistance was met during retraction and a piece of the stent separated in the patient anatomy.A covered stent was used to embed the separated portion of the absolute pro stent.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.

• Brand Name: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
• Common Device Name: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7878242
• Report Number: 2024168-2018-07193
• Device Sequence Number: 19348270
• Product Code: NIO
• UDI-Device Identifier: 08717648175732
• UDI-Public: 08717648175732
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/14/2018

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: 03/31/2021
• Device Catalogue Number: 1012530-100
• Device Lot Number: 8040361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/14/2018
• 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