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

Catalog Number	1012537-60
Medical Device Problem Codes	Material Separation (1562); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.A visual and functional inspection was performed on the returned device.The deployment issue and stent separation (fracture) were not confirmed as the stent was not returned and the rack was fully retracted.There were no fractured pieces of the stent implant in the sheath and there was no fracture on the shaft of the delivery system.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Review of the complaint history of the reported lot revealed no other incidents.The investigation was unable to determine a conclusive cause for the reported deployment issue.It should be noted that retracting the delivery system with the partially deployed stent would cause the stent to separate.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 that the 9.0x60 mm absolute pro stent was advanced to the heavily calcified, right external iliac artery, but only partially deployed.The catheterization lab staff documented a fracture on the device, but the physician's notes did not mention this device.The vessel was treated with balloon dilatation using an 8.0x40 mm armada.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information provided.
Event or Problem Description
Subsequent to the previously filed report, it was noted that the 9.0x60 mm absolute pro stent was removed, without deployment.Although the catheterization (cath) lab documented a partial stent deployment, another cath lab nurse reviewed the angiography images from that procedure and confirmed that the undeployed stent was removed from the anatomy with the stent delivery system.A fractured stent was unable to be seen on the angiogram by the cath lab nurse.There was no additional information provided.
Additional Manufacturer Narrative
Correction: implant date changed to n/a.(b)(4).

• 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: 7966031
• Report Number: 2024168-2018-07911
• Device Sequence Number: 11121137
• Product Code: NIO
• UDI-Device Identifier: 08717648176234
• UDI-Public: 08717648176234
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2018

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: 03/31/2021
• Device Catalogue Number: 1012537-60
• Device Lot Number: 8042461
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 112