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

Catalog Number 1009528-18

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

Patient Problems Death (1802); Perforation (2001)

Event Date 06/08/2020

Event Type  Death  

Manufacturer Narrative

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 perforation and death are listed in the xience v everolimus eluting coronary stent systems 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.The additional xience v device referenced is being filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat a mildly tortuous de novo mid left anterior descending artery that was 90% stenosed.A 2.75x23mm and 2.75x18mm xience v stents were deployed in an overlapping fashion both via single inflation at 14 atmospheres (atm) for 15 seconds.Post-dilatation with a 3.0mm balloon was performed.Afterwards, a perforation was seen at the site of the overlapped stents.The patients condition started deteriorating and declining.A 2.8x26mm rx graftmaster was deployed at one inflation at 13 atm for 10 seconds to seal the perforation, which it sealed successfully.There was no leakage noted.The patients condition further deteriorated and the physician attempted pericardial tapping (pericardiocentesis), but the patient soon expired.Per the physician the rx graftmaster did not cause or contribute to the patients death.The cause of death was noted to be the perforation.An autopsy was not performed.No additional information was provided.

• Brand Name: XIENCE DRUG ELUTING CORONARY STENT
• 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 # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10197080
• MDR Text Key: 196488439
• Report Number: 2024168-2020-05340
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2022
• Device Catalogue Number: 1009528-18
• Device Lot Number: 0012941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 68 YR