MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE ALPINE; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1128350-15

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Ischemia (1942); Cardiogenic Shock (2262)

Event Date 09/06/2019

Event Type  Death  

Manufacturer Narrative

Exemption number (b)(4).The device remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The xience proa device is currently not commercially available in the u.S.; however, it is similar to a device sold in the us.

Event Description

It was reported that the procedure was performed to treat a proximal left anterior descending (lad) lesion.The 3.50x15mm xience proa stent was implanted successfully.A few hours later, the patient had cardiac shock and needed to be resuscitated.The patient was returned to the cath lab and it was noted there was reduced blood flow in the distal lad.The lesion was dilated using a non-abbott balloon then a 2.75x33mm xience pro stent was placed.The perfusion was restored successfully but due to the cardiogenic shock the circulation couldn't be fully restored, and the patient died.According to the physician the patient died due to protracted cardiogenic shock.In the physician¿s opinion the death was because of the general condition of the patient and not because of the placed stents.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001.The device was not returned for evaluation.The reported patient effects of death and ischemia are listed in the xience pro a everolimus eluting coronary stent systems instructions for use, as a 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.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.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.

Event Description

It was reported that the procedure was performed to treat a proximal left anterior descending (lad) lesion.The 3.50x15mm xience proa stent was implanted successfully.A few hours later, the patient had a cardiac shock and needed to be resuscitated.The patient was returned to the cath lab and it was noted there was reduced blood flow in the distal lad.The lesion was dilated using a non-abbott balloon then a 2.75x33mm xience pro stent was placed.The perfusion was restored successfully but due to the cardiogenic shock the circulation couldn't be fully restored, and the patient died.According to the physician the patient died due to a protracted cardiogenic shock.In the physician¿s opinion the death was because of the general condition of the patient and not because of the placed stents.No additional information was provided.

• Brand Name: XIENCE ALPINE
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 9158545
• MDR Text Key: 161276037
• Report Number: 2024168-2019-12376
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2022
• Device Catalogue Number: 1128350-15
• Device Lot Number: 9041861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death