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

Catalog Number	1012529-60
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/09/2018
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.Evaluation summary: visual inspection and fourier transform infrared spectrometer (ftir) testing was performed on the returned device.The reported complaint was confirmed.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 the loose material in the sealed header bag appears to be related to a potential product quality issue.The issue is being addressed per internal operation procedures.Abbott vascular will continue to trend the performance of these devices.The additional two absolute pro devices referenced in b5 are being filed under separate medwatch reports.
Event or Problem Description
It was reported that during incoming inspection of an 7x60mm absolute pro vascular self-expanding stent system (sess) a small piece of white foreign material was found inside the sterile pouch.A small piece of black foreign material was found inside the sterile pouch of an 8x40mm absolute pro vascular sess and a small piece of purple foreign material was found inside the sterile pouch of an 8x100mm absolute pro vascular sess.The inner pouches were intact and the sterility of the devices was not compromised.The incident occurred during an inspection of a consignment return at the distribution center.The sess was not used.There was no patient involvement.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: 8062194
• Report Number: 2024168-2018-08718
• Device Sequence Number: 2879845
• Product Code: NIO
• UDI-Device Identifier: 08717648175633
• UDI-Public: 08717648175633
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/12/2018

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: 09/30/2019
• Device Catalogue Number: 1012529-60
• Device Lot Number: 6102861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1