MAUDE Adverse Event Report: ABBOTT VASCULAR OMNILINK ELITE; PERIPHERAL STENT DELIVERY SYSTEM

Catalog Number	1012624-19
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2019
Type of Reportable Event	Serious Injury
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 will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The other additional omnilink referenced is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a de novo lesion in the non-tortuous, heavy calcified, 90% stenosed right subclavian artery.An unspecified omnilink stent was implanted on an unknown date in the right subclavian artery and had developed re-stenosis.On (b)(6) 2019, an 8x19mm omnilink elite stent delivery system (sds) was attempted to cross distal to the previously implanted stent but was unable to cross due to the stent.During removal, the tip of an unspecified sheath interacted with the sds, and the stent dislodged.A snare was used to retrieve the dislodged stent, and a non-abbott balloon dilatation catheter was used to successfully complete the procedure.There were no adverse patient sequelae and no clinically significant delay in the procedure.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.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 similar incidents and/or complaints from this lot.Based on the information provided, the reported difficulties appear to be due to case circumstances.The omnilink stent delivery system (sds) failed to cross the previously implanted omnilink elite stent and during removal, the stent dislodged.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
Subsequent to the initially filed report, the following information was received: additional information received indicates that there was no re-stenosis in the previously implanted omnilink stent.However, due to the inconsistencies of the reported information, the re-stenosis may have occurred.The 8x19mm omnilink elite stent may not have failed to cross due the implanted stent, but due to the inconsistencies of the reported information, the implanted stent may have caused the failure to cross.No additional information was provided.

• Brand Name: OMNILINK ELITE
• Common Device Name: PERIPHERAL STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9086356
• Report Number: 2024168-2019-11903
• Device Sequence Number: 2819151
• Product Code: NIO
• UDI-Device Identifier: 08717648179280
• UDI-Public: 08717648179280
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110043
• 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): 11/19/2019

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 Expiration Date: 08/31/2021
• Device Catalogue Number: 1012624-19
• Device Lot Number: 8031941
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 11/02/2019
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 11/19/2019
• 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