MAUDE Adverse Event Report: AV-TEMECULA-CT MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

Catalog Number	1007823-18
Health Effect - Clinical Codes	Thrombosis (2100); Foreign Body In Patient (2687)
Date of Event	03/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents.The reported patient effect of thrombosis as listed in the multi-link vision coronary stent systems (css)instructions for use is a known patient effect that may be associated with coronary stenting.The investigation determined the reported failure to advance, stent dislodgement, difficult to remove foreign body in patient and subsequent treatments appear to be related to circumstances of the procedure; however, a conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined.In addition, the investigation was unable to determine a conclusive cause for the reported irregular appearance.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 2.5 x 18 mm mini vision stent delivery system was prepared for use per instructions for use (ifu).The physician commented that the device looked different than usual and was told that the device was prepared per ifu and no issues were noted.The device was advanced into the patient anatomy, via brachial artery access, and had difficulty crossing.The device was pulled back and resistance was noted.Upon removal, it was noted that the stent had dislodged.The procedure was completed with implantation of a second mini vision, via the femoral artery.Post procedure, the patient was taken back to interventional radiology, in order to retrieve the dislodged stent.It was noted that the vessel, where the dislodged stent remained, had thrombosed and tissue plasminogen activator (tpa) was administered.The stent could not be retrieved and remains in the patient anatomy.The patient was discharged to home in stable condition.No additional information was provided.

• Brand Name: MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM
• Common Device Name: CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6476291
• Report Number: 2024168-2017-02964
• Device Sequence Number: 13665633
• Product Code: MAF
• UDI-Device Identifier: 08717648049521
• UDI-Public: (01)08717648049521(17)190930(10)6102441
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2017

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: 09/30/2019
• Device Catalogue Number: 1007823-18
• Device Lot Number: 6102441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2017
• Initial Report FDA Received Date: 04/10/2017
• 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
• Patient Age: 52 YR