MAUDE Adverse Event Report: ABBOTT VASCULAR HT VERSATURN GUIDE WIRE

Model Number	1013317J
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); Foreign Body In Patient (2687)
Date of Event	07/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the patient presented experiencing a non-st-elevation myocardial infarction.The left anterior descending (lad) coronary artery was 99% occluded.The diagonal branch was 70% occluded.The versaturn guide wire was advanced into the diagonal artery to keep the pathway to artery open and a non-abbott drug eluting stent (des) was implanted in the lad, jailing the versaturn guide wire.During removal of the guide wire, the distal portion of the wire broke off.A non-abbott stent was implanted in the diagonal to treat the lesion and to stabilize the distal portion of the separated wire.The proximal portion of the separated guide wire was embedded into the vessel wall of the lad.The final outcome of the procedure was good.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned guide wire and the reported core separation was confirmed.Additionally, stretched coils were noted.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 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 difficulties appear to be related to operational circumstances of the procedure.Based on the reported information, a non-abbott drug eluting stent was implanted in the lad, jailing the versaturn guide wire.Manipulation of the guide wire during retraction likely resulted in the reported core separation and noted stretched coils.Additionally, the reported treatment appears to be related to the operational context of the procedure as a non-abbott stent was implanted in the diagonal to treat the lesion and to stabilize the distal portion of the separated wire and embed the proximal portion of the separated guide wire into the vessel wall.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: HT VERSATURN GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10405202
• Report Number: 2024168-2020-06761
• Device Sequence Number: 2961141
• Product Code: DQX
• UDI-Device Identifier: 08717648198472
• UDI-Public: 08717648198472
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K141782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2020

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: 05/31/2022
• Device Model Number: 1013317J
• Device Catalogue Number: 1013317J
• Device Lot Number: 0060861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 09/29/2020
• 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: PROMUS PREMIERE 3.5X16MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Weight: 60