MAUDE Adverse Event Report: ABBOTT VASCULAR MULTI-LINK RX VISION CORONARY STENT SYSTEM; CORONARY STENT DELIVERY SYSTEM

Model Number	1007849-08
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for investigation.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 procedure was performed to treat a lesion in the left coronary circumflex (lcx).Before the procedure, it was noted that the patient had previously undergone a procedure in the same region.A 3.50 x 08 mm rx vision stent delivery system (sds) was prepped per the instructions for use and the stent was confirmed to be on the balloon prior to inserting the sds into the patient anatomy.The sds was advanced to the target lesion; however, the sds failed to cross the lesion.The sds was removed and it was noted that the stent was dislodged from the balloon.The stent could not be seen through echocardiography; therefore, a new 3.0 x 08mm unspecified stent was used and successfully implanted to the target lesion.Then, an unspecified balloon was inserted and inflated and dragged up the guide wire in an attempt to retrieve the dislodged stent; however, the stent was not retrieved.A ct scan was performed but the stent could not be seen in the anatomy.The procedure ended at this point.No additional treatment was performed.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stent dislodgement was confirmed.The reported failure to advance could not be tested as it was based on operational circumstances.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 did not indicate a lot specific quality issue.Based on the case information and analysis of the returned device, a conclusive cause for the reported difficulties cannot be determined; however, the subsequent treatments appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.Outcomes attributed to ae incorrectly selected as other serious on initial report.

• Brand Name: MULTI-LINK RX VISION CORONARY STENT SYSTEM
• Common Device Name: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10567751
• Report Number: 2024168-2020-07899
• Device Sequence Number: 11439178
• Product Code: MAF
• UDI-Device Identifier: 08717648050688
• UDI-Public: 08717648050688
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2020

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: 04/30/2022
• Device Model Number: 1007849-08
• Device Catalogue Number: 1007849-08
• Device Lot Number: 9050341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 10/15/2020
• 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: Other; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 110