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

Catalog Number	1007847-18
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).Evaluation summary: a visual and dimensional inspection was performed on the returned device.The reported stent dislodgement was confirmed.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 similar incidents from this lot.The multi-link vision rapid exchange (rx) instructions for use (ifu) instructs to prepare the device by expelling all air from the device prior to use and to verify that the stent does not extend beyond the radiopaque balloon markers.Do not use if any defects are noted.The ifu deviations do not appear to have directly caused or contributed to the reported stent dislodgement.The investigation determined that the reported stent dislodgement appears to be related to circumstances of the procedure and 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 protective sheath was removed from the 2.75 x 18 mm vision stent delivery system (sds) without issue.The device was then prepared for use inside the anatomy.The sds was advanced to the right coronary artery target lesion, but the stent was not on the sds.The stent was found inside the protective sheath.Another vision stent was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• 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: 6488969
• Report Number: 2024168-2017-03091
• Device Sequence Number: 16340864
• Product Code: MAF
• UDI-Device Identifier: 08717648050572
• UDI-Public: (01)08717648050572(17)190228(10)6032241
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2017

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: 02/28/2019
• Device Catalogue Number: 1007847-18
• Device Lot Number: 6032241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2017
• Initial Report FDA Received Date: 04/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1