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

Catalog Number	1012624-39
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified lesion in the common iliac artery with no tortuosity.No resistance was noted during advancement and the balloon of the 8x39 mm omnilink stent delivery system (sds) was inflated twice and ruptured at nominal pressure.The stent was successfully implanted.There was no issue removing the balloon and there were no adverse patient effects.There was no reported 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.Visual analysis was performed on the return device.The reported balloon rupture 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 identified no other similar incidents and/or complaints from this lot.The investigation determined that the reported balloon rupture was due to case circumstances.It is likely that the balloon rupture was the result of interaction with the calcified lesion.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 9227443
• Report Number: 2024168-2019-12901
• Device Sequence Number: 1564734
• Product Code: NIO
• UDI-Device Identifier: 08717648179303
• UDI-Public: 08717648179303
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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: 06/30/2022
• Device Catalogue Number: 1012624-39
• Device Lot Number: 9010441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 11/16/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6F SHEATH