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

Catalog Number	1145300-18
Health Effect - Clinical Code	Death (1802)
Date of Event	10/24/2017
Type of Reportable Event	Death
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.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported difficulties.The reported patient effect of death is listed in the xience alpine everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect, and the relationship to the product, if any, 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 patient presented with an acute myocardial infarction.Angiography confirmed total occlusions in the circumflex (cx) and left anterior descending arteries, and 99% occlusion in the right coronary artery.The 3.0x18mm otw alpine stent delivery system (sds) was advanced to the mid cx and during attempted deployment, the indeflator would not hold pressure and the balloon would not fully inflate, therefore the stent did not fully deploy.A balloon rupture was suspected as blood entered the indeflator.The sds was removed and a 3.0x15mm nc trek balloon catheter was used to deploy the stent in the target lesion with no issues.A balloon pump was inserted and the patient was transferred to another hospital where he expired later that day.It is unknown if an autopsy was performed.The cause of death was not reported; however, it was not thought to be device related.No additional information was provided.

• Brand Name: XIENCE ALPINE OTW 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: 7016428
• Report Number: 2024168-2017-08864
• Device Sequence Number: 1238969
• Product Code: NIQ
• UDI-Device Identifier: 08717648200076
• UDI-Public: 08717648200076
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• 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): 11/09/2017

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: 02/01/2020
• Device Catalogue Number: 1145300-18
• Device Lot Number: 7020241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 11/09/2017
• 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: Death
• Patient Age: 80 YR