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

Catalog Number	1125225-12
Health Effect - Clinical Codes	Intimal Dissection (1333); Low Blood Pressure/ Hypotension (1914)
Date of Event	11/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of intimal dissection and hypotension are listed in the xience alpine, everolimus eluting coronary stent system, instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the moderately tortuous, heavily calcified, mid left anterior descending (lad) coronary artery.A 2.25 x 12 mm xience alpine stent implant was successfully deployed.Following stent deployment, something hazy was seen under angiography in the left main coronary artery, possible dissection.However, nothing was done to confirm that it was a dissection and no treatment was performed.The patient's blood pressure dropped, dopamine was administered, and an intra-aortic balloon pump (iabp) was used to help bring up the patient's blood pressure.The patient left the cath lab in stable condition.No other 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: 7134716
• Report Number: 2024168-2017-09972
• Device Sequence Number: 13739545
• Product Code: NIQ
• UDI-Device Identifier: 08717648199066
• UDI-Public: 08717648199066
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/20/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2020
• Device Catalogue Number: 1125225-12
• Device Lot Number: 7090741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 12/20/2017
• 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: 69 YR