MAUDE Adverse Event Report: ABBOTT VASCULAR HT BALANCE GUIDE WIRE

Model Number	1001782-HC
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Device Damaged by Another Device (2915); Difficult to Advance (2920)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	02/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned to abbott vascular for analysis.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 similar incidents and/or complaints reported from this lot.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported difficult to advance, difficulty to remove, device damaged by another device and guide wire tip separation appears to be related to operational circumstances of the procedure.Based on the reported information, during advancement through the previously implanted stents, the guide wire encountered resistance and became trapped under the stent struts.Manipulation during retraction against resistance likely resulted in the tip separation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The ostial xience sierra referenced is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that this was a very complex case in a heavily calcified and heavily tortuous right coronary artery (rca) with 90% stenosis which required multiple devices, multiple predilatations, and atherectomy.Four overlapping xience sierra stents were implanted along the length of the rca with the fourth stent extending into the ostium.There was good flow and good hemodynamics.Ivus (intravascular ultrasound) was performed and showed no dissections.Post-dilatation was performed along the entire length of the four stents with a 3.0x30 noncompliant balloon dilatation catheter (bdc) at 20 to 24 atmospheres.During removal of the bdc it was difficult to remove from the non-abbott guide wire, so both were removed as a unit.The bmw (balance middle weight) guide wire was advanced, but became caught under a stent strut in the ostial rca.When the wire was retracted, approximately 1 to 2 mm of the tip separated from the guide wire.A snare was unable to be used because additional guide wires were unable to advance through the stent struts.The prolonged attempts to remove the wire referenced in the attached 3500 mw were referring to the attempts to advance another guide wire through the stent struts.The bmw tip was trapped behind the stent strut.The patient has since been discharged from the hospital and is reported to be doing well.No additional information was provided.A voluntary 3500 medwatch report was received that states: the patient underwent a pci of heavily calcified 90% tandem lesions in a tortuous mid rca.During the procedure, a run-through wire was loaded and a fine cross catheter was used to cross serial stenoses in the mid rca and passed into the distal rca.A balloon was advanced into the mid rca but could not be advanced to the more distal severe stenosis.There was a significant waist in the balloon.An atheretomy was performed and was successful at crossing both mid rca stenoses.Despite multiple maneuvers, a promus elite drug-eluting stent could not be deployed into the mid to distal rca.Therefore, this was removed and aggressive predilatation was performed.A sion blue wire was advanced into the distal rca to act as a buddy wire.Wires [balloons] were then advanced over the sion blue wire and predilatation was performed.Four xience sierra stents were deployed extending to the ostium.There was no evidence of proximal or distal stent edge dissection.Postdilatation was then started.While trying to remove the balloon, it was noted that the balloon was stuck to the sion wire and therefore both of them had to be removed as a unit.It was very difficult to rewire through the stent struts into the rca.A bmw wire was used.While trying to remove the wire, the very tip of the wire, @ 1 to 2 mm, sheared off and was wedged behind the stent strut at the ostium.After prolonged attempts to remove the tip of the wire, further attempts were abandoned as the risk of causing dissection in the vessel or even the aorta would be increased with further attempts.Post procedure, the vessel had timi-3 flow, the patient was free of angina and was hemodynamically stable.

• Brand Name: HT BALANCE GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9953234
• Report Number: 2024168-2020-03583
• Device Sequence Number: 654851
• Product Code: DQX
• UDI-Device Identifier: 08717648025990
• UDI-Public: 08717648025990
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K021228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020

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: 09/30/2020
• Device Model Number: 1001782-HC
• Device Catalogue Number: 1001782-HC
• Device Lot Number: 8100571
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OSTIAL XIENCE SIERRA STENT; THREE XIENCE SIERRA STENTS IN RCA
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Weight: 93