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

Catalog Number	1125300-23
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/23/2016
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 of the reported lot did not indicate a lot specific quality issue.The investigation determined an interaction with the heavily calcified lesion contributed to the failure to cross and difficulties removing the device, such that the stent became disrupted on the balloon, and thus subsequently dislodged.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 the procedure was to treat a lesion located in the mid left anterior descending (lad) artery with heavy calcification.After pre-dilatation was performed, a 3.0 x 23 mm xience alpine rx stent delivery system (sds) was advanced to the lesion; however, the sds would not cross the heavily calcified lesion.When the sds was being removed from the anatomy, resistance was felt and the stent dislodged from the device.The dislodged stent was observed to be floating in the left main artery.An unknown balloon was used to push the dislodged stent into the lad and subsequently implanted it in the proximal lad.It was reported that the proximal lad was also diseased.Another sds was used to complete the procedure by implanting a stent in the distal lad.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: 6256118
• Report Number: 2024168-2017-00515
• Device Sequence Number: 16368644
• Product Code: NIQ
• UDI-Device Identifier: 08717648199363
• UDI-Public: (01)08717648199363(17)190906(10)6082941
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/17/2017

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: 09/06/2019
• Device Catalogue Number: 1125300-23
• Device Lot Number: 6082941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2016
• Initial Report FDA Received Date: 01/17/2017
• 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: 87 YR
• Patient Weight: 82