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

Catalog Number	1003381-13
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.It should be noted that the ultra rapid exchange (rx) coronary stent system instructions for use states: an unexpanded stent may be retracted into the guiding catheter one time only.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 and stent detachment appear to be related to the operational context of the procedure; however, the reported stent dislodgement appears to be related to the use error.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 lesion located in the right coronary artery (rca).The 4.5 x 13 mm ultra stent delivery system (sds) was advanced; however, would not cross the lesion.The sds was retracted and a 3.5 x 8 mm balloon catheter was then used to dilate the rca.Upon examination of the sds it was determined that there was no damage to the 4.5 x 13 mm ultra sds; therefore, it was reinserted; however, again it would not cross the lesion.Upon retraction of the sds a second time it was observed that the stent implant had dislodged and remained in the rca.There was no resistance felt during removal of the sds.After numerous attempts to snare the stent failed, a 1.2 mm balloon catheter was inserted into the stent and inflated enough to grab the stent, which then was able to be brought down almost to the femoral artery insertion site.At this time open heart surgeons were called to do a groin exploration to remove the stent from the body.They removed the stent piece by piece from the patient.The patient has recovered with no further complications.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: 6284931
• Report Number: 2024168-2017-00762
• Device Sequence Number: 733130
• Product Code: MAF
• UDI-Device Identifier: 08717648035265
• UDI-Public: (01)08717648035265(17)180430(10)6050541
• 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): 01/27/2017

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: 04/30/2018
• Device Catalogue Number: 1003381-13
• Device Lot Number: 6050541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2017
• Initial Report FDA Received Date: 01/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 66