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

Catalog Number	1007848-28
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	08/30/2016
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.The device was not returned for analysis.Although the anatomical conditions were not reported, it is likely the device interacted with the anatomy during advancement resulting in the reported failure to advance.Further interaction with the edge of the guiding catheter during retraction of the stent delivery system (sds) likely contributed to the reported material deformation (mangled stent), causing the reported difficult to remove, ultimately causing the stent to dislodge from the balloon.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 incidents.The investigation determined the reported failure to advance, stent dislodgement, material deformation, difficult to remove, device embedded in vessel or plaque and treatment appears to be due to the circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
Event or Problem Description
Sus voluntary event report was received stating the following: report #: mw5066282.On (b)(6) 2016, a cardiac cath was attempted to be performed by physician via the right radial artery.Initial vision stent was unable to be advanced in coronary; became mangled and unable to be drawn back in to guide catheter.When trying to remove from body, stent came off of stent balloon system.Multiple, varied attempts to remove but unsuccessful.Stent crushed to side wall or radial artery.Patient remained without pain in arm during and after cath.Vascular surgery was consulted.Notes states that at this time the radial artery appears to be patent.Abbott multi-link vision stent delivery system size: 3.0 x 28 mm ref# 1067848-28 lot# 6032241, exp date: 02/28/2019.

• Brand Name: MULTI-LINK RX VISION 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: 6228916
• Report Number: 2024168-2017-00156
• Device Sequence Number: 443872
• Product Code: MAF
• UDI-Device Identifier: 08717648050657
• UDI-Public: (01)08717648050657(17)190228(10)6032241
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/06/2017

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: 02/28/2019
• Device Catalogue Number: 1007848-28
• Device Lot Number: 6032241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2016
• Initial Report FDA Received Date: 01/06/2017
• 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