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

Catalog Number	1007850-12
Medical Device Problem Codes	Inflation Problem (1310); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2019
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.Concomitant medical products: guide catheter: guidezilla.Evaluation summary: a visual and functional inspection was performed on the returned device.The reported inflation issue was not confirmed.The reported physical resistance 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 identified no similar incidents from this lot.The investigation determined the reported physical resistance appears to be related to circumstances of the procedure.There was no damage or leak noted to the stent delivery system (sds) during the inspection prior to use or during preparation for use.Based on the information provided, a definitive cause for the reported inflation cannot be determined.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 de novo lesion in a moderately calcified mid left anterior descending artery.Pre-dilatation was performed with a cutting balloon catheter and a guideliner was used.A 4.0 x 12 mm vision stent delivery system was used and met initial resistance with the anatomy.The stent delivery balloon was inflated to a nominal pressure of 9 atmospheres and deflated without any issues.However, the stent was still on the balloon when the device was removed from the anatomy.There was a waist in the stent delivery balloon.Therefore, a 4.0 x 18 mm vision stent was implanted to successfully 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: 8317650
• Report Number: 2024168-2019-00947
• Device Sequence Number: 19079270
• Product Code: MAF
• UDI-Device Identifier: 08717648050770
• UDI-Public: 08717648050770
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2019

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: 03/31/2020
• Device Catalogue Number: 1007850-12
• Device Lot Number: 7040541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 120