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

Catalog Number	1012631-19
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant products: guide wire: spindle, radifocus, guide cath: 6f destination, 7f mach 1.(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
Event or Problem Description
It was reported that the procedure was to treat a 70% stenosis in the left common iliac with mild tortuosity and mild calcification using a radial approach.A 6f guiding sheath was used and pre-dilatation was performed with 6.0 x 40 mm balloon.The 8.0 x 19 mm omnilink elite stent delivery system was advanced to the lesion and inflated slowly from 4 atmospheres (atm) to 14 atm, but an indentation was noted in the balloon.An attempt was made to deflate the balloon, but it would not deflate at all; therefore, the balloon was inflated slowly to 18 atm and the balloon indentation resolved and the stent was fully expanded.The balloon still would not deflate so the sheath was moved to the balloon and repeated attempts to deflate were still unsuccessful.A 7f guiding catheter was used from the left femoral and a snare device captured the guide wire and was removed from the femoral.A 7f guideliner and a 4.0 x 40 mm balloon were advanced from the femoral to retrieve the omnilink elite sds, but failed.An attempt was made to rupture the balloon using a guide wire, but the balloon would not rupture.A snare was used to pull the inflated balloon to the femoral puncture site, but the balloon could not be pulled into the sheath.Ultimately a femoral cut down was performed to retrieve the balloon.The procedure took about 3 hours.There was no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Evaluation summary: the device was returned for analysis and abbott vascular (av) could not confirm the reported deflation issue due to the condition of the returned device.A review of the lot history record revealed no nonconformities related to the reported event.The complaint handling database was reviewed and there was one similar event for this lot.Root cause analysis concluded that the event was potentially related to a manufacturing issue.Av implemented corrective actions to address this issue and the actions have been determined to be effective.Av will continue to trend the performance of these devices.

• 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: 6443597
• Report Number: 2024168-2017-02631
• Device Sequence Number: 19078739
• Product Code: NIO
• UDI-Device Identifier: 08717648178498
• UDI-Public: (01)08717648178498(17)180430(10)4110641
• 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,Followup
• Report Date (Section B): 06/05/2017

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: 04/30/2018
• Device Catalogue Number: 1012631-19
• Device Lot Number: 4110641
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2017
• Supplement Report FDA Received Date: 06/05/2017
• 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