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

Catalog Number	1007849-23
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation summary: a visual and dimensional inspection was performed on the returned device.The reported shaft detachment was confirmed.The reported failure to advance and difficult to remove 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, as it is likely the device interacted with the mildly tortuous, moderately calcified, 95% stenosed lesion during advancement resulting in the reported failure to advance.Further interaction with the challenging anatomy during advancement/retraction likely caused the reported difficult to remove, ultimately causing the shaft to separate.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.The 3.5x23mm and 3.0x18mm rx vision devices are being filed under separate medwatch reports.
Event or Problem Description
It was reported that the procedure was to treat a 95% stenosed, mildly tortuous and moderately calcified lesion in the proximal left anterior descending artery.Following pre-dilatation, a 3.5x23mm rx vision stent delivery system (sds) failed to cross due to the anatomy and the proximal shaft separated.Resistance removing the sds was felt.A second 3.5x23mm rx vision sds was advanced and the stent was deployed without issues.Upon removal, the sds became frozen on the allstar guide wire and the proximal shaft separated.After the separation, the sds could be removed.A 3.0x18mm rx vision sds was being advanced; however, resistance advancing the sds over the guide wire outside of the patient anatomy was felt.The decision was made not to use it and during removal, resistance was also met with the guide wire.The procedure was successfully completed with a new 3.0x18mm rx vision stent and the same allstar guide wire.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: 7480585
• Report Number: 2024168-2018-03225
• Device Sequence Number: 11148723
• Product Code: MAF
• UDI-Device Identifier: 08717648050725
• UDI-Public: 08717648050725
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/02/2018

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: 09/30/2019
• Device Catalogue Number: 1007849-23
• Device Lot Number: 6102641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 74