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

Catalog Number	1007850-15
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: a visual and dimensional inspection was performed on the returned device.The reported shaft detachment 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.The investigation determined the reported difficulties appear to be related to the operational context 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
It was reported that the procedure was to treat a heavily calcified lesion in the circumflex (cx).The 4.0x15mm rx vision stent delivery system (sds) was advanced however failed to cross the lesion.The hypotube separated during advancement.As the separation was outside the anatomy, the device was simply removed without resistance.The procedure was completed with another device.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
Event or Problem Description
Subsequent to the initially filed report, a user facility medwatch was received with the following information: during advancement of the stent, the shaft of the stent broke outside of the body.The stent was pulled out and was not delivered.A new stent was pulled and placed without difficulty.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Correction: patient information updated.Description of event.Initial report sent to fda.Report source.(b)(4).

• 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: 7965413
• Report Number: 2024168-2018-07908
• Device Sequence Number: 182828
• Product Code: MAF
• UDI-Device Identifier: 08717648050787
• UDI-Public: 08717648050787
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 1007850-15
• Device Lot Number: 7031541
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/09/2018
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 93