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

Catalog Number	1003382-18
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.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 failure to advance, stent dislodgement and foreign body in patient appears 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.
Event or Problem Description
It was reported that the procedure was to treat a moderately tortuous and heavily calcified right coronary artery.A 6f guide was being used and a 5.0 x 28 mm ultra stent delivery system was advanced to the lesion and the stent was deployed.The stent delivery system was removed without issue.A 5.0 x 18 mm ultra was being advanced to treat the lesion proximal to the deployed stent when the stent caught on calcium in the artery and the stent implant partially dislodged and was partially expanded in the artery.It is unknown if the device was completely in healthy tissue.A 5.0 balloon catheter was used for post dilatation and a 4.0 unspecified xience stent was implanted to bridge the two ultras.There was no adverse patient sequela reported.No additional information was provided.

• Brand Name: ACS MULTI-LINK RX ULTRA 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: 6848103
• Report Number: 2024168-2017-07322
• Device Sequence Number: 1430887
• Product Code: MAF
• UDI-Device Identifier: 08717648035319
• UDI-Public: 08717648035319
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P020047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/07/2017

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: 11/30/2018
• Device Catalogue Number: 1003382-18
• Device Lot Number: 6120841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT: ULTRA 5.0X28
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR