MAUDE Adverse Event Report: ST. JUDE MEDICAL ULTIMUM EV HEMOSTASIS INTRODUCER WITH TIP MARKER; INTRODUCER, CATHETER

Model Number	C407699
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Occlusion (1984); Stenosis (2263); Vascular Dissection (3160)
Date of Event	07/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
After a successfull portico implant, the ultimum 19f was removed.An angio control has showed a complete occlusion of the left cfa.A tea and an artery reconstruction with a biocompatible tissue was performed.An angio post intervention showed a left cfa stenosis: a pta was performed with a 7 mm balloon with good final result.
Additional Manufacturer Narrative
Additional information was received that this event was not related to the ultimum introducer and is therefore not reportable to the ultimum introducer.
Event or Problem Description
On (b)(6) 2018, a 27 mm portico valve was implanted with a 19 fr portico delivery system.After a successful portico implant, the ultimum ev hemostasis introducer was removed.An angio control showed complete occlusion of the left cfa.A tea and an artery reconstruction with a biocompatible tissue was performed.An angio post intervention showed a left cfa stenosis and a pta was performed with a 7 mm balloon with good final result.The patient is reported to be recovering.The operators and the vascular surgeon believes the closure systems (2 proglide) has moved a huge calcification, next to the femoral bifurcation, that has occluded the cfa.On (b)(6), the physician indicated the cause of the occlusion was a dissection that was created during use of the portico delivery system or ultimum ev hemostasis introducer.
Additional Manufacturer Narrative
An event of a vessel occlusion and dissection was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: ULTIMUM EV HEMOSTASIS INTRODUCER WITH TIP MARKER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7774698
• Report Number: 3005334138-2018-00258
• Device Sequence Number: 1011616
• Product Code: DYB
• UDI-Device Identifier: 05415067014382
• UDI-Public: 05415067014382
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K140327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/25/2018

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?: No
• Operator of Device: No Information
• Device Expiration Date: 02/29/2020
• Device Model Number: C407699
• Device Catalogue Number: C407698
• Device Lot Number: 6381038
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 09/12/2018; 10/17/2018; 10/25/2018
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 09/13/2018; 10/23/2018; 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR