MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE STEELCORE 18 LT GUIDE WIRE WITH MICROGLIDE COATING

Catalog Number	1007710
Health Effect - Clinical Codes	Intimal Dissection (1333); Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	02/07/2017
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.(b)(6).Concomitant medical products: inflation: 20/30 copilot; guide catheter: 6fr jr-4; vascular solutions guideliner 7fr v3 150cm; sheath: 6fr shuttle; stent: 5.0x50mm gore viabahn covered stent; cook medical zilver 518 6x40mm; other: cook medical cxi support catheter 2.6fr.018in x150cm; vessel closure: prostar xl clsr 10fr; 6fr perclose proglide (x2).Product performance engineering reviewed the incident information; however, there was no reported device malfunction and the product was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of intimal dissection, hemorrhage and perforation, as listed in the instructions for use, are known adverse events associated with the use of a peripheral device in native peripheral arteries.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the patient presented with a perforation with extravasation in the left renal artery just distal to a deployed 5.0x50mm non-abbott covered stent for treatment of an existing aneurysm.Reportedly, the perforation was most likely caused by a hi-torque (ht) steelcore 18 lt 300cm guide wire (gw); while there were no device issues and the gw was easily advanced, it caused a dissection which became a perforation.An attempt was made to advance another non-abbott covered stent over the ht steelcore gw, but the stent failed to advance due to patient anatomy.The stent and steelcore gw were withdrawn and a smaller gw (spartacore 14 st 5.0x300cm) was advanced.A 4.5x26mm rx graftmaster covered stent was then successfully advanced over the spartacore and was deployed overlapping the distal end of the non-abbott covered stent, successfully sealing the perforation.A 5.0x28mm rx ultra bare metal stent (bms) was then successfully deployed inside of the non-abbott covered stent (but not in the graftmaster) per routine procedure to ensure optimal apposition and sealing of only the non-abbott stent, followed by post-dilatation with a non-abbott balloon.A final angiogram confirmed successful placement of the stent grafts with full exclusion of the bleeding and no evidence of endoleaks, and a resultant timi 3 flow.The left and right common femoral artery access sites were closed using a prostar xl clsr 10fr and two 6fr perclose proglide vessel closure devices were used without issue.The patient received 1 unit of packed red blood cells as a result of the perforation.The patient tolerated the procedure well with no complications.No additional information was provided.

• Brand Name: HI-TORQUE STEELCORE 18 LT GUIDE WIRE WITH MICROGLIDE COATING
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6422312
• Report Number: 2024168-2017-02379
• Device Sequence Number: 13588445
• Product Code: DQX
• UDI-Device Identifier: 08717648014123
• UDI-Public: (01)08717648014123
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K980119
• 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): 03/21/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1007710
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2017
• Initial Report FDA Received Date: 03/21/2017
• 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: 84 YR
• Patient Weight: 63