MAUDE Adverse Event Report: AV-TEMECULA-CT OMNILINK ELITE PERIPHERAL STENT SYSTEM

Catalog Number	1012631-39
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical devices: guide wire: agosal, sheath: parent.Evaluation summary: a visual and functional inspection were performed.The reported difficult to deploy and leak were unable to be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A query of the complaint handling database for the reported lot revealed no other incidents reported for leaks or difficult to deploy.The investigation was unable to determine a conclusive cause for the reported difficult to deploy and leak.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 procedure was to treat a non-tortuous, mildly calcified, and de novo right common iliac artery.An 8.0 x 39 omnilink elite balloon expandable stent (bes) was advanced to the target lesion.The bes was inflated at 6 atmospheres and before the balloon fully inflated (only the proximal part of the balloon had inflated), the stent jumped approximately 1 cm and landed outside the lesion.A leak from the inflation port was confirmed.A non-abbott balloon was advanced to move the stent to the target lesion.Post-dilatation was performed with a non-abbott balloon and the procedure was successfully completed.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.

• Brand Name: OMNILINK ELITE PERIPHERAL STENT SYSTEM
• Common Device Name: PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7119448
• Report Number: 2024168-2017-09754
• Device Sequence Number: 1210262
• Product Code: NIO
• UDI-Device Identifier: 08717648178511
• UDI-Public: 08717648178511
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2017

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: 03/31/2018
• Device Catalogue Number: 1012631-39
• Device Lot Number: 4100241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 12/14/2017
• 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