MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

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

Patient Problems Death (1802); No Consequences Or Impact To Patient (2199)

Event Date 07/11/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The scaffold remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that a patient died in the cath lab.Further, it was stated that the patient in 2017 was treated with an absorb gt1 bioresorbable vascular scaffold.No additional information was provided.

Manufacturer Narrative

(b)(4).The patient died in the cath lab due to acute coronary syndrome (acs), having been symptomatic at the time of death with a cardiac arrest.Angiography was performed and it was determined that the absorb stent was patent and no thrombus was observed.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the previously filed medwatch report, additional information received confirmed patient died due to acute coronary syndrome (acs), having been symptomatic at the time of death with a cardiac arrest.Angiography was performed and it was determined that the absorb stent was patent and no thrombus was observed.Date of death remains unknown.No additional information was provided.

• Brand Name: ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7737232
• MDR Text Key: 115643379
• Report Number: 2024168-2018-05919
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 07/31/2018
• Supplement Dates Manufacturer Received: 08/17/2018
• Supplement Dates FDA Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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