MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number	1125250-23
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	05/16/2017
Type of Reportable Event	Serious Injury
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.Evaluation summary: the device was returned for analysis.The reported stent dislodgement was able to be confirmed.The reported failure to advance the device was unable to be replicated in a testing environment as it was based on operational circumstances.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.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.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that on (b)(6) 2017, the procedure was to treat a heavily calcified lesion in the proximal circumflex (cx) coronary artery.After pre-dilating the lesion a 2.5 x 23 mm rx xience alpine stent delivery system (sds) was advanced, but the sds failed to cross due to a difficult vessel turn and heavy calcification at the ostial cx, prior to reaching the lesion.Force was applied and the stent dislodged at the left main (lm) to proximal cx area.After removing all devices as a single unit, the dislodged stent was able to be pulled back to the left main using a snare device, but was unable to be retrieved.The dislodged stent was then crushed against the vessel wall of the lm and cx ostium using a balloon, followed by deployment of an additional unspecified stent to secure the crushed stent.Treatment of the target lesion was abandoned with future plans for treatment, and the patient was transferred in stable condition to the intensive care unit (icu) for observation as a precaution.There were no adverse patient sequelae.As of (b)(6) 2017, the patient was doing well and due to be discharged the following day.No additional information was provided.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6616347
• Report Number: 2024168-2017-04823
• Device Sequence Number: 16345802
• Product Code: NIQ
• UDI-Device Identifier: 08717648199189
• UDI-Public: (01)08717648199189(17)191215(10)6120841
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• 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): 06/06/2017

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: 12/15/2019
• Device Catalogue Number: 1125250-23
• Device Lot Number: 6120841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2017
• Initial Report FDA Received Date: 06/06/2017
• 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: Hospitalization; Required Intervention