MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE PRO 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1017300-48

Device Problems Deflation Problem (1149); Entrapment of Device (1212); Material Separation (1562)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

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 identified no other incidents from this lot.The reported patient effects of hypotension and tachycardia are listed in the xience pro 48 everolimus eluting coronary stent systems instructions for use (ifu) as known patient effects of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported deflation issues; however, factors that may contribute to deflation issues include, but are not limited to, the device, contamination in the inflation lumen, patient anatomical morphology, patient disease state, deflation technique, contrast dilution, and inadequate connection to the deflation device.The investigation determined the reported material separation, entrapment of the device and treatment appear to be related to circumstances of the procedure.It is likely the deflation issues contributed to the reported entrapment of the device and subsequent shaft separation with the patient effects and treatments of hypotension, tachycardia, treatment with medications, surgical procedure, hospitalization, and additional therapy/non-surgical treatment.There is no indication of a product quality issue with respect to manufacture, design or labeling.The xience pro is currently not commercially available in the us; however, it is similar to a device sold in the us.

Event Description

It was reported that the patient presented experiencing a non-st-elevation myocardial infarction due to a blocked left anterior descending coronary artery (lad).The lesion was pre-dilated, then a xience pro 3.0 x 48 mm was inserted into the lad.The stent was deployed and implanted, but the stent delivery system balloon failed to deflate and was stuck in the stent.Troubleshooting was performed, but the balloon remained stuck and the shaft separated.The patient became unstable.Blood pressure dropped and the patient experienced recurrent ventricular tachycardia.Medication was administered.The proximal shaft of the delivery system was removed, and the patient was taken to surgery for device removal and recovered without further issue.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported material separation was confirmed.The reported entrapment of the device could not be replicated in a testing environment as it was related to operational context of the procedure.The reported deflation issues could not be confirmed due to the condition the device was received for analysis.The investigation was unable to determine a conclusive cause for the reported deflation issues; however, factors that may contribute to deflation issues include, but are not limited to, the device, contamination in or damage to the inflation lumen, patient anatomical morphology, patient disease state, deflation technique, contrast dilution, and inadequate connection to the deflation device.The investigation determined the reported material separation, entrapment of the device and treatment appear to be related to circumstances of the procedure.It is likely the deflation issues contributed to the reported entrapment of the device and subsequent shaft separation with the patient effects and treatments of hypotension, tachycardia, treatment with medications, surgical procedure, hospitalization, and additional therapy/non-surgical treatment.There is no indication of a product quality issue with respect to manufacture, design or labeling.D10, h3 - device available for evaluation h6: method code 4114 - removed.

• Brand Name: XIENCE PRO 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10165683
• MDR Text Key: 195530870
• Report Number: 2024168-2020-05124
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2022
• Device Catalogue Number: 1017300-48
• Device Lot Number: 9121141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Date Manufacturer Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention